[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurodegenerative-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurodegenerative-diseases":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,74,130,158,190,247,271,318,340,393,422,449,479,503,520,537,559,591,613,635,666,689,717,752,774],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":54,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100270060","neurologic-stem-cell-treatment-study-100270060",false,"NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.","ALL","18 Years",{"count":21,"type":22},500,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Neurologic Disorders","Nervous System Diseases","Neurodegenerative Diseases","Neurological Disorders","Stroke","Traumatic Brain Injury","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","Progressive Supranuclear Palsy","ALS","Amyotrophic Lateral Sclerosis","Neuropathy","Diabetic Neuropathies","Alzheimer Disease","Dementia","Frontotemporal Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[55,56,32,33,57,58,46,59,37,52,49,60],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy","Neurodegeneration","RECRUITING","2026-06-24",{"date":64,"type":65},"2026-06-26","ACTUAL",{"date":67,"type":65},"2016-06",{"date":69,"type":22},"2028-07-31",{"name":71,"class":72},"MD Stem Cells","INDUSTRY",3,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":99,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":73},"100496255","cognitive-reserve-and-response-to-speech-language-intervention-in-bilingual-speakers-with-primary-progressive-aphasia-100496255","NCT05741853","Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia","Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia","Inclusion Criteria:\n\n* Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)\n* Bilingual in Spanish and Catalan or bilingual in Spanish and English\n* Different proficiency levels across languages are expected, any prior experience in both languages is acceptable\n* Intervention study: Score of 15 or higher on the Mini-Mental State Examination\n* Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of 10 or higher on the Mini-Mental State Examination\n\nExclusion Criteria:\n\n* Other central nervous system or medical diagnosis that can cause symptoms\n* Other psychiatric diagnosis that can cause symptoms\n* Significant, uncorrected visual or hearing impairment that would interfere with participation\n* Prominent initial non-speech-language impairments (cognitive, behavioral, motoric)\n* Intervention Study: Score of less than 15 on the Mini-Mental State Examination\n* Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of less than 10 on the Mini-Mental State Examination",true,"40 Years",{"count":84,"type":22},60,[25],"Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA.\n\nThe overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how \"strong\" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.",[88,49,89,48,30,90,91,92,93,94,95,96,97,98],"Primary Progressive Aphasia","Dementia, Frontotemporal","Frontotemporal Lobar Degeneration","Apraxia, Motor","Dysarthria","Communication Disorders","Language Disorders","Speech Disorders","Neurocognitive Disorders","Aphasia","Bilingual Aphasia",[100,101,102,88,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119],"Dementia, ADRD","Bilingualism","Multilingualism","Bilingual Primary Progressive Aphasia","Cognitive Reserve","Language Decline","Bilingual Language Decline","Speech-Language Therapy","Bilingual Speech-Language Therapy","Spanish speakers","Spanish-Catalan Bilinguals","Spanish-English Bilinguals","Hispanic","Catalán","Catalan","Spanish","Castellano","Speech Therapy","Latino","Cognition","2026-06-08",{"date":122,"type":65},"2026-06-10",{"date":124,"type":65},"2023-05-01",{"date":126,"type":22},"2027-11-30",{"name":128,"class":129},"Stephanie Grasso","OTHER",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":81,"sex":18,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100634883","retinal-hyperspectral-imaging-in-neurodegenerative-diseases-100634883","NCT07545473","Retinal Hyperspectral Imaging in Neurodegenerative Diseases","Inclusion Criteria:\n\n1. Aged over 30 years.\n2. Have dementia or a neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy body dementia, Niemann-Pick type 2 or vascular dementia (age-matched and sex-matched controls will also be recruited).\n3. With the exception of participants with Parkinson's disease and Lewy body disease, for whom clinical examination by a neurologist is sufficient to establish a clinical diagnosis of probable dementia with Lewy Body or probable Parkinson disease dementia, all participants must have previously undergone at least of one of the following tests to help to confirm a clinical diagnosis of dementia or neurodegenerative disease: genetic tests, blood biomarker tests (amyloid, tau, neurofilament light), a brain amyloid beta PET scan, or cerebrospinal fluid tests.\n4. Have a minimum best corrected visual acuity level of 6\u002F60 in both eyes and no major eye problems, such as advanced age-related macular degeneration, advanced glaucoma, or greater than moderate non-proliferative diabetic retinopathy.\n5. Be willing to participate in the study and attend the Centre for Eye Research Australia.\n6. Be accompanied by a friend or family member.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)\n3. Known contraindication to pharmacological pupil dilation\n4. Any condition that, in the investigator's opinion, would compromise participant safety or image quality","30 Years",{"count":138,"type":22},930,[25],"Hyperspectral retinal imaging is a non-invasive imaging modality in which a series of images of the retina are captured using light of different wavelengths. The resulting \"hypercube\" of data provides a wealth of information about the retinal structure. Our group has developed evidence supporting a role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. We are undertaking further studies to establish the role of this method in the assessment of people with dementia, or those at risk of Alzheimer's disease. In addition, we wish to test whether the approach may have value in other forms of dementia or neurodegenerative disease such as Parkinson's disease, Lewy-Body dementia or vascular dementia.",[49,30,48,142,50,143,51,144],"Parkinson Disease","Vascular Dementia","Niemann-Pick Diseases",[146,147],"Hyperspectral imaging","Retina","2026-04-21",{"date":150,"type":65},"2026-04-22",{"date":152,"type":65},"2021-10-11",{"date":154,"type":22},"2028-12-31",{"name":156,"class":129},"Center for Eye Research Australia",1,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":18,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100522861","study-to-evaluate-the-efficacy-and-safety-of-atnc-mdd-v1tms-with-cognitive-training-in-mild-alzheimers-dementia-100522861","NCT06088121","Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia","Effects of a ATNC MDD-V1 (TMS With Cognitive Training), for the Treatment of Mild Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study","ATC-P001","Inclusion Criteria:\n\n1. Patients who started drug treatment with an acetylcholinesterase inhibitor at least 2 months before participating in the clinical trial and can participate in the clinical trial without changing the dose during the trial period.\n2. Male or female age 60-85 years.\n3. Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.\n4. A patient whose dementia was confirmed to be due to Alzheimer's disease by amyloid PET-CT.\n5. MMSE score 21 to 26.\n6. CDR 1 or GDS 3.\n\n   ※ For subjects who are excluded from screening based on criteria 5 or 6, if the investigator judges that the subject is likely to be eligible, one repeat screening may be performed.\n7. A patient who is deemed physically eligible for the clinical trial based on medical records and physical examination.\n8. A patient who is unable to provide voluntary informed consent for the clinical trial due to impaired decision-making capacity, for whom a legally authorized representative provides consent for participation, and who can attend follow-up visits with a caregiver.\n9. Patients who agreed to participate in all 24-week clinical trials.\n10. Patients with normal ability to see and hear letters.\n11. Patients who speak Korean as their mother tongue\n\nExclusion Criteria:\n\n1. Patients with central nervous system (CNS) disorders that may affect cognitive function (such as cerebrovascular diseases including vascular dementia, subdural hematoma, normal pressure hydrocephalus, brain tumors, CNS infections like HIV or syphilis, head trauma, Huntington's disease, Parkinson's disease, etc.) where cognitive decline may be explained by other causes, or in whom dementia types other than Alzheimer's disease are suspected.\n2. Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic examination.\n3. History of Epileptic Seizures or Epilepsy.\n4. Patients with a history of drug abuse, including alcohol, in the past 5 years from the time of screening.\n5. Patients with schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress, severe anxiety, mental retardation, DSM-V disorder.\n6. Patients with abnormal vitamin B12, folic acid deficiency, or thyroid stimulating hormone (TSH) test results that were considered by the investigator to affect or are caused by the severity of dementia.\n7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants.\n8. Cardiac pacemakers.\n9. Implanted medication pumps.\n10. Intracardiac lines.\n11. Patients who are currently taking medications that lower the convulsive seizure threshold.\n12. Significant heart disease.\n13. Patients with severe renal or hepatic impairment※, referring to conditions that significantly affect daily living (e.g., stage 4 chronic kidney disease), with the assessment based on the investigator's judgment.\n14. Contraindication for performing MRI scanning.\n15. Contraindication for performing amyloid PET-CT scanning.\n16. Patients who do not consent to TMS treatment and participation in this clinical trial.\n17. Patients who participated in other clinical trials 3 months before participating in this clinical trial.\n\n    ※ Subjects who participate in non-interventional studies (such as observational studies) that do not affect the subject's disease or symptoms may be enrolled in the study.\n18. Patients with a history of TMS treatment within the last 2 years before participating in this clinical trial.\n19. Patients judged by the investigator to be unsuitable for participation in clinical trials for other reasons.\n\n    ※ If the test subject is unable to visit according to the research plan due to unavoidable personal circumstances during the screening period, it will be treated as a screening dropout, and the patient can participate in the study after re-agreeing according to the future schedule.\n20. Patients with a history of malignant tumors within the last 5 years.\n\n    \\- Participation is possible if more than 5 years have elapsed without recurrence after the decision to be cured (The point of complete removal of the tumor through surgery or the end of chemotherapy, etc.).\n21. Patients who need to take medications suggested in concomitantly contraindicated drugs.","60 Years","85 Years",{"count":169,"type":22},180,[25],"The study tests the effect of the ATNC MDD-V1 on Alzheimer patients' cognitive function. The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training.",[173,49,174,175,29,30,96,176],"Alzheimer's Disease","Brain Diseases","Central Nervous System Diseases","Mental Disorder",[178,179,180,49],"TMS","Cognitive Stimulation","ATNC MDD-V1",{"date":182,"type":65},"2026-04-23",{"date":184,"type":65},"2023-05-15",{"date":186,"type":22},"2027-06-30",{"name":188,"class":72},"Advanced Technology & Communications",11,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":167,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":200,"conditions":201,"keywords":220,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100567749","phase-3-a-phase-3-study-of-ntla-2001-in-attrv-pn-100567749","NCT06672237","A Phase 3 Study of NTLA-2001 in ATTRv-PN","MAGNITUDE-2: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN)","Inclusion Criteria:\n\n* Diagnosis of ATTRv-PN\n* Karnofsky Performance Status (KPS) ≥ 60\n\nExclusion Criteria:\n\n* Other causes of amyloidosis (amyloidosis caused by non-TTR protein)\n* Other known causes of sensorimotor or autonomic neuropathy\n* Diabetes mellitus\n* New York Heart Association Class III or IV heart failure\n* Liver failure\n* Hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Prior receipt of a TTR silencer (Small interfering RNA (siRNA) or Antisense oligonucleotides (ASOs))\n* Estimated Glomerular Filtration Rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Unable or unwilling to take vitamin A supplementation for the duration of the study\n* History of liver disease",{"count":84,"type":22},[199],"PHASE3","This study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (NTLA-2001) compared to placebo in participants with ATTRv-PN.",[202,203,204,205,30,206,207,208,29,209,210,211,212,213,214,215,216,217,218,219],"Neuromuscular Disease","Neuromuscular Diseases (NMD)","Neurodegenerative Disease","Neurodegenerative Disease, Hereditary","Neuromuscular Diseases","Nerve Disorders","Nervous System Disease","Genetic Disease, Inborn","Amyloidosis, Familial","Amyloidosis, Hereditary","Amyloidosis","Polyneuropathies","Amyloid Neuropathies","Amyloid Neuropathies, Familial","Peripheral Nervous System Disease","Peripheral Nervous System Diseases","Metabolism, Inborn Errors","Metabolic Diseases",[221,212,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236],"TTR","Polyneuropathy","NTLA-2001","ATTR","ATTR-PN","ATTRv-PN","Transthyretin","TTR-mediated amyloidosis","Amyloidosis, hereditary","Amyloidosis, hereditary, transthyretin-related amyloidosis","Transthretin amyloid polyneuropathy","TTR PN","TTR polyneuropathy","nexiguran ziclumeran","nex-z","CRISPR","2026-04-13",{"date":239,"type":65},"2026-04-16",{"date":241,"type":65},"2024-11-22",{"date":243,"type":22},"2028-08",{"name":245,"class":72},"Intellia Therapeutics",14,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":261,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":4},"100630609","novel-technologies-to-measure-vision-related-quality-of-life-100630609","NCT07489898","Novel Technologies to Measure Vision-related Quality of Life","Feasibility Study of Novel Technologies to Measure Vision-related Quality of Life in Patients With Neurodegenerative Diseases Affecting the Optic Nerve or Retina","Tablet-VR","Inclusion Criteria:\n\n* Adults with neurodegenerative diseases affecting the optic nerve or retina who have sufficient manual dexterity to perform tablet-based and virtual reality headset-based tests. Informed consent will be received.\n\nExclusion Criteria:\n\n* Those under the age of 18 years old\n* Those who do not have sufficient manual dexterity to perform the tablet-based and virtual reality headset-based tests",{"count":256,"type":22},50,"OBSERVATIONAL","Traditional ways of measuring vision, such as reading letters on an eye chart, do not fully reflect the real-life visual problems experienced by people with eye diseases. Many patients report difficulties with things like contrast, recognising faces, and identifying items whilst shopping - challenges that are not captured by standard clinical tests.\n\nAs a result, it is hard to understand the true impact of these conditions on everyday life, or to measure how well new treatments are working.\n\nSome new treatments for eye diseases have shown promise, but clinical trials have often struggled to show clear benefits. This is largely because the tools used to measure vision changes in trials are not sensitive enough to detect the kinds of improvements that matter most to patients.\n\nThis pilot study will explore whether novel, technology-based tests, delivered via tablets and virtual reality headsets, can better measure meaningful changes in vision and quality of life. These tools are designed to be more engaging and reflective of real-world visual tasks, such as navigating environments or detecting objects in low light.\n\nFifty participants with neurodegenerative diseases affecting the optic nerve or retina will take part in the study. Researchers will assess how feasible and acceptable these new tools are to patients and whether the results they produce align more closely with patients' lived experiences.\n\nUltimately, this research aims to improve how we assess vision in clinical trials, so that future treatments can be properly tested and approved based on measures that truly reflect patients' needs. If successful, it could lead to better-designed trials, more effective treatments, and improved quality of life for people living with visual impairment.",[30,260],"Inherited Optic Neuropathy","NOT_YET_RECRUITING","2026-03-18",{"date":264,"type":65},"2026-03-24",{"date":266,"type":22},"2026-04",{"date":268,"type":22},"2030-03-01",{"name":270,"class":129},"Nisha Nixon",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":278,"maxAge":136,"enrollmentInfo":279,"targetDuration":281,"studyType":257,"phases":4,"briefSummary":282,"conditions":283,"keywords":289,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":157},"100466506","hereditary-spastic-paraplegia-genomic-sequencing-initiative-hspseq-100466506","NCT05354622","Hereditary Spastic Paraplegia Genomic Sequencing Initiative (HSPseq)","Investigating the Genetic Basis of Hereditary Spastic Paraplegia","Inclusion Criteria:\n\n* Clinical diagnosis of progressive spasticity","1 Month",{"count":280,"type":22},200,"5 Years","The purpose of the HSP Sequencing Initiative is to better understand the role of genetics in hereditary spastic paraplegia (HSP) and related disorders. The HSPs are a group of more than 80 inherited neurological diseases that share the common feature of progressive spasticity. Collectively, the HSPs present the most common cause of inherited spasticity and associated disability, with a combined prevalence of 2-5 cases per 100,000 individuals worldwide.\n\nIn childhood-onset forms, initial symptoms are often non-specific and many children may not receive a diagnosis until progressive features are recognized, often leading to a significant diagnostic delay. Genetic testing in children with spastic paraplegia is not yet standard practice. In this study, the investigators hope to identify genetic factors related to HSP. By identifying different genetic factors, the investigators hope that over time we can develop better treatments for sub-categories of HSP based on cause.",[284,30,285,286,287,288],"Hereditary Spastic Paraplegia","Pediatric Disorder","Spasticity, Muscle","Motor Neuron Disease","Movement Disorders",[284,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309],"Neurodegenerative disease","Spasticity","SPG3a","SPG4","SPG11","SPG15","SPG26","SPG47","SPG50","SPG51","SPG52","Complex hereditary spastic paraplegia","Early Onset hereditary spastic paraplegia","Movement disorder","Adaptor protein complex 4","Neurogenetic disorder","Genetic Disease","Muscle Spasticity","Neurodevelopmental disorders","Musculoskeletal Disease","2026-03-16",{"date":262,"type":65},{"date":313,"type":65},"2022-04-25",{"date":315,"type":22},"2027-04-29",{"name":317,"class":129},"Boston Children's Hospital",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":81,"sex":18,"minAge":19,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":261,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100629135","early-phase-1-study-on-the-application-of-f-fcob04-a-mao-b-targeted-pet-imaging-agent-in-neurodegenerative-diseases-100629135","NCT07470710","Study on the Application of ¹⁸F-FCOB04, a MAO-B Targeted PET Imaging Agent, in Neurodegenerative Diseases","Inclusion Criteria:\n\n1. Aged between 18 and 75 years, regardless of gender.\n2. Patients diagnosed with probable or possible neurodegenerative diseases by a specialist neurologist according to current internationally recognized clinical diagnostic criteria, including but not limited to Alzheimer's disease, Parkinson's disease, and Parkinsonian syndromes (such as progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, etc.).Diagnosis is based on a comprehensive evaluation including systematic medical history collection, neurological examination, relevant neuropsychological or motor function scale assessments, combined with conventional structural neuroimaging such as cranial MRI.Patients with a history of brain surgery, brain cyst, brain tumor, or other comorbidities that may affect data analysis are excluded.\n3. Prior to any assessment, the subject or their legal representative has understood and signed the written informed consent form.\n4. Subjects who are currently using, or have not used MAO-B inhibitors (including but not limited to selegiline, rasagiline, safinamide) for ≥14 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Suffering from other severe neurological diseases, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, immunodeficiency or other severe systemic disorders.\n2. Suffering from claustrophobia.\n3. History of substance abuse or excessive alcohol consumption.\n4. Female subjects who are pregnant or breastfeeding.\n5. Presence of any condition that, in the opinion of the investigator, may be harmful or potentially harmful to the subject in any procedure related to this study.","75 Years",{"count":326,"type":22},40,[328],"EARLY_PHASE1","In this clinical trial, we intend to perform 18F-FCOB04 PET imaging in patients with neurodegenerative diseases to observe the brain uptake of this tracer.We will investigate the distinct imaging patterns of brain MAO-B expression in patients with various neurodegenerative diseases.Correlation analysis will be conducted between imaging findings and relevant clinical indicators.This study aims to evaluate the role of 18F-FCOB04 in the auxiliary diagnosis of neurodegenerative diseases, as well as to assess the tolerability and safety of the tracer and the imaging procedure.",[30],"2026-03-10",{"date":333,"type":65},"2026-03-13",{"date":335,"type":22},"2026-03-09",{"date":337,"type":22},"2026-12-31",{"name":339,"class":129},"Peking Union Medical College Hospital",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":81,"sex":18,"minAge":347,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":359,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":157},"100617877","slowing-cognitive-decline-in-alpha-synucleinopathies-by-enhancing-physical-activity-100617877","NCT07324330","Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity","ALPHA-FIT","Inclusion Criteria:\n\niRBD:\n\n* Age: 50-80 years\n* Polysomnographically confirmed diagnosis of iRBD\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nHealthy controls:\n\n* Age: 50-80 years\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nExclusion Criteria:\n\niRBD:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n\nHealthy controls:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n* clinically diagnosed iRBD","50 Years","80 Years",{"count":350,"type":22},130,[25],"α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.\n\nThe aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.\n\nEighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the \"Deutsches Zentrum für Neurodegenerative Erkrankungen\" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.",[142,354,30,355,175,356,29,357,174,358],"Prodromal Stage","Basal Ganglia Diseases","Synucleinopathies","Cerebral Disorder","Parkinsonian Disorders",[360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,40,380,381,382,383],"intervention","movement","iRBD","prodromal parkinson's","non-pharmacologic","alpha-synucleinopathy","biomarker","cognitive decline","executive function","MRI","lifestyle","prevention","RCT","motor decline","smartphone","smartwatch","accelerometer","scalable","prodromal","PD","Lewy-body","MSA","multiple system atrophy","dementia","2026-01-14",{"date":386,"type":65},"2026-01-16",{"date":388,"type":65},"2025-12-04",{"date":390,"type":22},"2029-12-01",{"name":392,"class":129},"University Hospital, Bonn",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":81,"sex":18,"minAge":19,"maxAge":348,"enrollmentInfo":401,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":157},"100613552","validation-of-the-viradia-app-for-neurological-and-cognitive-diagnostics-in-virtual-reality-100613552","NCT07268079","Validation of the VIRADIA App for Neurological and Cognitive Diagnostics in Virtual Reality","Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the Assessment of Neurological and Cognitive Functions","VIRADIA","Inclusion Criteria:\n\n* Age 18-80 years.\n* Ability to provide informed consent.\n* Adequate vision and hearing to complete testing.\n* For the neurological group: confirmed diagnosis of a neurological disorder (e.g., Parkinson's disease, multiple sclerosis, or similar).\n* For the control group: no history of neurological or psychiatric disease.\n\nExclusion Criteria:\n\n* Severe cognitive impairment (MMSE \\\u003C 24 or equivalent clinical judgment).\n* Acute neurological or psychiatric condition interfering with testing.\n* Severe motor disability preventing task performance (e.g., inability to use VR controller).\n* Current substance abuse.\n* Uncorrected visual impairment or vestibular disorder leading to intolerance of VR.",{"count":280,"type":22},"The VIRADIA study aims to validate and assess the reliability of a newly developed Virtual Reality (VR) diagnostic platform designed for neurological and cognitive testing. The goal is to determine whether the VR versions of nine commonly used clinical tests measure the same constructs and provide comparable results to their traditional face-to-face or paper-based forms.\n\nThe study includes two groups of participants: (1) healthy volunteers and (2) patients with neurological diagnoses. Each participant will complete both the standard and the VR versions of the tests, with the order of administration randomly assigned. The tested functions cover fine motor skills, gait and balance, attention, executive function, processing speed, and visuospatial abilities.\n\nThe following tests are included in the VR platform: 9-Hole Peg Test (9HPT), 6 Meter Walk Test, Timed Up and Go - Manual (TUG-M), Functional Reach Test (FRT), Symbol Digit Modalities Test (SDMT), Clock Drawing Test (CDT), Trail Making Test (TMT A\u002FB), Stroop Test, and SATURN Test.\n\nParticipants will first provide informed consent and basic demographic information. They will then complete all tests in both modalities (standard and VR), with appropriate breaks between tasks.\n\nThe study is observational, within-subjects, and paired in design. Primary outcomes include correlation and agreement between VR and standard test scores (validity). Data will be analyzed using paired statistical methods, including Pearson\u002FSpearman correlations, Bland-Altman analysis, and Intraclass Correlation Coefficients (ICC).\n\nNo medication or invasive intervention is used in this study. The VR testing is non-invasive and carries minimal risk. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804).\n\nThe results will provide evidence for the validity and reliability of VR-based diagnostics and support the use of the VIRADIA platform as a safe, standardized tool for neurological and cognitive assessment.",[31,52,404,30],"Motor Impairment",[406,407,408,409,410,411,412],"Virtual Reality","Neurological Diagnostics","Cognitive Assessment","Motor Function","Neuropsychology","Validity","Digital Health","2025-12-03",{"date":415,"type":65},"2025-12-05",{"date":417,"type":22},"2025-12-01",{"date":419,"type":22},"2026-05-01",{"name":421,"class":129},"Gametherapy",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":81,"sex":18,"minAge":19,"maxAge":324,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":261,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":445,"leadSponsor":447,"locationsCount":4},"100610789","phase-1-clinical-research-on-stem-cell-therapy-for-parkinsons-disease-100610789","NCT07232147","Clinical Research on Stem Cell Therapy for Parkinson's Disease","Clinical Study on the Safety, Tolerance and Preliminary Efficacy of Human Mesenchymal Stem Cell Therapy for Parkinson's Disease","Inclusion Criteria:\n\nThe participants must meet all of the following criteria to be included in this study:\n\n1. The participants must fully understand and comply with the research procedures, voluntarily participate in the study and sign the informed consent form;\n2. At the time of signing the informed consent, the participants must be aged 18 or above and under 75 years old, with no gender restrictions;\n3. During the screening process, the participants must have had primary Parkinson's disease for at least 5 years, have a confirmed medical history record and meet the diagnostic criteria for primary Parkinson's disease as defined by the International Parkinson and Movement Disorder Society (MDS);\n4. During the screening, according to the MDS-UPDRS scoring scale, the Hoehn-Yahr classification of the \"off\" period of drug treatment is 2 to 4;\n5. During the screening, the score of the third part of the MDS-UPDRS in the \"off\" period must be greater than 30;\n6. During the screening, the stable duration of Parkinson's disease and the stable duration of the optimized drug dosage must be at least 4 weeks, and the duration of levodopa use must be at least 1 year;\n7. During the screening, the participants must have a response to levodopa treatment, and the levodopa loading test must be positive;\n8. The participants must experience a decline in the efficacy of anti-Parkinson's disease treatment, which affects their quality of life;\n9. The participants must have good compliance and be able to cooperate with the completion of the assessment items of the trial; For participants with reproductive potential and their partners, they must be free from pregnancy plans for at least 2 weeks before the screening to at least 1 year after the administration of the drug, and must agree to take effective non-drug contraceptive measures during the trial (such as condoms, non-drug intrauterine devices, etc.), except for those who have taken permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.\n\nExclusion Criteria:\n\nIf the subjects meet any of the following criteria, they will not be included in this study:\n\n1. Allergic to the study drug or its excipients, or allergic to similar drugs of the study drug, or have a history of severe allergies (including any food allergy or drug allergy);\n2. Have a previous history of mental disorders, serious diseases, or other significant diseases that may affect safety;\n3. Have a known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibody positive), or acquired immunodeficiency syndrome-related diseases, or positive HIV serological test results;\n4. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody positive;\n5. Previously diagnosed with secondary or atypical Parkinson's syndrome caused by drugs, metabolic disorders, or other reasons;\n6. Previously diagnosed with epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological diseases;\n7. Have new or unstable mental symptoms within 1 year before screening (such as mental confusion, severe depression, or tendencies towards self-harm\u002Fsuicide);\n8. Have a history of dementia or severe cognitive dysfunction; or have obvious dementia or cognitive dysfunction at screening; the 1.1 part of the MDS-UPDRS score at screening is \\> 3; due to dementia, the subject's compliance is affected, diary cannot be accurately recorded, and\u002For the informed consent cannot be signed;\n9. Have other serious systemic diseases at the time of screening;\n10. Have any history of malignant tumors in the past;\n11. Are participating in other clinical trials, or have participated in other clinical studies within 3 months before administration and received intervention treatment;\n12. Have active infections at the screening period, and still need systemic application of antibiotics, antifungal, antiviral treatment at baseline and the infection has not been controlled;\n13. Have a history of stroke, unstable angina pectoris, or myocardial infarction attack within 6 months before screening;\n14. Have a history of schizophrenia or other severe mental disorders, drug or alcohol abuse;\n15. Pregnant or lactating women; Subjects deemed unsuitable for participation in the study by the investigator's comprehensive assessment.",{"count":430,"type":22},20,[432],"PHASE1","This study, through different administration methods, adopted a randomized, double-blind, placebo-controlled trial design to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells (hUC-MSCs) in patients with Parkinson's disease, explore their initial effectiveness and the relationship between biological active factors and therapeutic efficacy. The \"Clinical Study on the Treatment of Parkinson's Disease with Human Umbilical Cord Mesenchymal Stem Cells\" of this study is expected to provide clinical trial evidence for the development of safe and effective clinical cell therapies for patients with Parkinson's disease.",[435,30,288],"Parkinson Disease (PD)",[437,438,439,440],"Parkinson's disease(PD)","Umbilical cord mesenchymal stem cells (hUC-MSCs)","Stem cell therapy","Safety and efficacy","2025-11-13",{"date":443,"type":65},"2025-11-18",{"date":417,"type":22},{"date":446,"type":22},"2027-12-31",{"name":448,"class":72},"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":459,"conditions":460,"keywords":465,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":157},"100458152","passive-sensor-identification-of-digital-biomarkers-to-assess-effects-of-orally-administered-nicotinamide-riboside-100458152","NCT05245903","Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside","Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress, and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia","Emerald-NRAD","Inclusion Criteria:\n\n* Ability of the participant and\u002For his\u002Fher legally authorized representative to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information.\n* Ability to speak and read fluently in English\n* 18-89 years old (inclusive)\n* Normal or corrected to normal hearing and vision\n* Meet clinical diagnostic criteria for MCI or Mild AD, according to the criteria outlined above\n* Study partner available for duration of trial participation\n* At least one copy of the APOE ε4 allele\n* An aggregate risk score \\> 4 according to the risk analysis method developed by Sabbagh et al. (2017)\n* For individuals who are taking niacin (or a vitamin supplement with niacin) of \\>200mg, the completion of a two-week wash-out period\n\nExclusion Criteria:\n\n* Current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician\n* Clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician\n* Lifetime history of psychotic disorder (i.e. Schizophrenia, Schizoaffective Disorder), as determined by study clinician\n* Diagnosis of a mitochondrial disorder\n* Any MRI safety contraindications\n* History of drug hypersensitivity or intolerance to NR\n* Transient ischemic attack or stroke within 1 year prior to screening\n* History of alcohol or substance abuse within prior year, as determined by study clinician and urine toxicology screen\n* History of head injury rated as moderate or worse, per DSM-5 criteria\n* History of seizure within prior 10 years\n* Current use of medication with known adverse effects on cognition (benzodiazepines, barbiturates, opiate analgesics, first generation antipsychotic medication, anticholinergics, sedating antihistamines, tricyclic anti-depressants)\n* Change in dose of any psychiatric medications within 4 weeks of screening visit\n* Prior use of L-DOPA, any anti-Parkinsonian medication, or prior treatment with anti-amyloid immunotherapy\n* Current use of putative mitochondrial enhancers or antioxidants (e.g. carnitine, creatine, Co-Q10, N-acetyl cysteine, pramipexole)\n* Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of screening\n* Prior use of prescription narcotics 4 weeks before screening\n* Female subjects who are pregnant or breastfeeding\n* The current use of niacin (or a vitamin supplement with niacin) \\>200mg within the last two weeks prior to study visit","89 Years",{"count":326,"type":22},"This project's main goal is to use state-of-the-art passive sensing techniques to identify digital biomarkers that relate to bioenergetic changes in the brain due to nicotinamide riboside supplementation in those with mild cognitive impairment and mild Alzheimer's dementia.",[48,461,49,52,462,30,96,463,464,176],"Dementia Alzheimers","Mild Cognitive Impairment","Neurocognitive Dysfunction","Cognitive Dysfunction",[466,467,468,462,469],"Passive sensing","Digital phenotyping","Alzheimer's Dementia","Digital biomarker","2025-11-04",{"date":472,"type":65},"2025-11-06",{"date":474,"type":65},"2022-05-31",{"date":476,"type":22},"2026-05-31",{"name":478,"class":129},"Mclean Hospital",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":487,"maxAge":348,"enrollmentInfo":488,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":157},"100479102","molecular-and-functional-imaging-in-monogenic-pd-100479102","NCT05518617","Molecular and Functional Imaging in Monogenic PD.","Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers","FOX_1","Inclusion Criteria:\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n\n  \\*\\*All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with serotonergic transmission (e.g. selective serotonin reuptake inhibitors, tricyclic antidepressant, triptans, etc).\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion Criteria:\n\n* Subjects lacking capacity according to investigator judgement.\n* Subjects with a clinical diagnosis of dementia as determined by the investigator.\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.","25 Years",{"count":489,"type":22},45,"In this study, the investigators aim to find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of PD symptoms.",[142,492,30,205,493],"Nervous System Disorder","Parkinson's","2025-10-01",{"date":496,"type":65},"2025-10-07",{"date":498,"type":65},"2022-07-01",{"date":500,"type":22},"2026-06-30",{"name":502,"class":129},"University of Exeter",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":487,"maxAge":167,"enrollmentInfo":511,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":519,"locationsCount":157},"100478957","serotonin-release-in-premotor-and-motor-pd-100478957","NCT05516732","Serotonin Release in Premotor and Motor PD","Evaluation of Serotonergic Neurotransmission in Premotor and Motor Parkinson's Disease.","FOX3","Inclusion criteria-\n\n* Subjects must understand the nature of the study and must provide signed and dated written HRA-approved informed consent in accordance with local regulations before any protocol-specific screening procedures are performed;\n* Males and females, age 25-85 years, inclusive;\n* Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative β-hCG test at screening. For sexually active subjects (except females of non-childbearing potential-e.g., at least 2 years postmenopausal or surgically sterile), condoms should be used in addition to other birth control methods for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. These patients must be willing to remain on their current form of contraception for the duration of the study. All male subjects must agree to refrain from donating sperm for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. Sexually active male subjects must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands (i.e. for 15 consecutive months following baseline PET and SPECT scans); agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands;\n* Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures;\n* Adequate visual and auditory acuity to complete the psychological testing;\n* In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.\n\nExclusion criteria -\n\n* Subjects lacking capacity according to investigator judgement;\n* Subjects taking serotonin acting drugs such as antidepressants (i.e. tricyclic or selective serotonin reuptake inhibitors etc.);\n* Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;\n* Subjects with current or a recent history of drug or alcohol abuse\u002Fdependence;\n* Subjects who have other neurological disorders and known intracranial co-morbidities such as stroke, hemorrhage, space-occupying lesions;\n* Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;\n* History of suicidal behaviour or active suicidal ideation;\n* Within 1 year prior to screen or between screen and baseline (Day -1), any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of, unstable angina; or syncope not related to PD;\n* History or presence of renal disease or impaired renal function;\n* Clinically important infection (e.g., chronic, persistent, or acute infection) within 30 days prior to screen or between screen and baseline (Day -1);\n* History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin;\n* Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology;\n* Use of antipsychotic medication within 3 months prior to screen or between screen and baseline (Day -1);\n* Use of any anticoagulant within 30 days prior to baseline and follow-up PET scans;\n* Use of any oral corticosteroid within 30 days prior to baseline and follow-up PET scans;\n* Use of metoclopramide within 30 days prior to baseline and follow-up (Day -1);\n* Use of any thyroid medication within 30 days prior to baseline and follow-up (Day -1);\n* Regular use (e.g., taken \\> 3 days\u002Fweek) of narcotic pain medications within 30 days prior to baseline and follow-up (Day -1);\n* Presence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g., Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body;\n* Negative modified Allen test in both hands, unless the brachial artery is used for arterial cannulation;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable;\n* History of severe skin allergy;\n* Patients who had previous surgery for PD (including but not limited to deep brain stimulation \\[DBS\\] or cell transplantation);\n* Patients who are treated with duodopa or apomorphine;\n* Initiation or change in pharmacologic therapy for symptoms of PD within 30 days prior to screen or between screen and baseline and follow-up (Day -1).\n* GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study).\n* STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.",{"count":5,"type":22},"In this study, the investigators aim to provide a deeper understanding of Parkinson's disease and find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of Parkinson's disease symptoms",[142,493,514,30,60,515],"Parkinson's Disease","Positron Emission Tomography",{"date":496,"type":65},{"date":498,"type":65},{"date":500,"type":22},{"name":502,"class":129},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":81,"sex":18,"minAge":487,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":157},"100478956","longitudinal-investigation-of-i2bs-in-pd-100478956","NCT05516719","Longitudinal Investigation of I2BS in PD","Longitudinal Investigation of Imidazoline-2 Binding Site as a Novel Marker of Disease Progression in Parkinson's Disease: An [11C]BU99008 PET Study","FOX_2","Inclusion criteria\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* Age 25 years or older.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n* All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine)\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion criteria\n\n* Subjects lacking capacity according to investigator's judgment;\n* Subjects with a clinical diagnosis of dementia as determined by the investigator;\n* Subjects with current or a recent history of drug or alcohol abuse\u002Fdependence;\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude the arterial cannulation and the safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Negative Allen test in both hands,\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of any medications with known actions on I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine);\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET, SPECT, or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;\n* History of suicidal behavior or active suicidal ideation;\n* Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;",{"count":529,"type":22},44,"In this study, the researchers aim to find a biomarker of PD. Using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The PET and SPECT scans use small amounts of radiation and specific compounds called tracers, to study chemical changes in the brain in a way not possible with any other procedure. The MRI uses magnetic fields to generate images of brain structure and function",[493,142,514,30,60,515],{"date":496,"type":65},{"date":534,"type":65},"2021-11-01",{"date":500,"type":22},{"name":502,"class":129},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":81,"sex":18,"minAge":347,"maxAge":167,"enrollmentInfo":544,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":157},"100455034","molecular-imaging-of-inflammation-in-parkinsons-disease-using-lps-and-tspo-petmr-100455034","NCT05205291","Molecular Imaging of Inflammation in Parkinson's Disease Using LPS and TSPO-PET\u002FMR","Molecular Imaging of LPS-induced Microglial Activation in Parkinson's Disease (PD). A TSPO PET-MR Imaging Study","Inclusion Criteria (all):\n\n* 50-85 years of age, male or female\n* Able to give informed consent\n* Adequate visual and auditory acuity to complete the neuropsychological testing\n* No presence or history of significant neurological or psychiatric disorders\n* BDI ≥ 20, moderate depression\n* No presence or history of inflammatory or autoimmune disorders\n* Negative family history for neurodegenerative diseases\n* Cognitively healthy (i.e., education-adjusted MoCA total score ≥ 26 points at screening)\n* Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).\n* Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).\n* Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.\n* Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.\n* Individuals must commit to not donating blood up to three months after the last PET scan.\n* Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal\u002Ffood intake).\n* Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.\n\nInclusion Criteria (Parkinson's disease patients):\n\n* 50-85 years of age, male or female\n* Able to give informed consent\n* Adequate visual and auditory acuity to complete the neuropsychological testing\n* No presence or history of other significant neurological or psychiatric disorders\n* Diagnosis of PD according to the Movement Disorder Society Clinical Diagnostic Criteria (Postuma et al., Mov Disord 2015)\n* Drug-naïve participants with PD must have a diagnosis of PD but must be therapy-free at the time of enrolment\n* For participants with PD-MCI: diagnosis of MCI according the diagnostic criteria for MCI-PD (Level I; Litvan et al., Mov Disord 2012) and\u002For MoCA \\\u003C 23\n* For participants with PD taking dopaminergic therapy: must be in stable therapy (i.e. not have changed therapy in the last 60 days)\n* Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).\n* Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).\n* Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.\n* Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.\n* Individuals must commit to not donating blood up to three months after the last PET scan.\n* Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal\u002Ffood intake).\n* Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.\n\nFor participants with iRBD:\n\nInclusion criteria:\n\n* 40-85 years of age, male or female\n* Able to give informed consent\n* Adequate visual and auditory acuity to complete the neuropsychological testing\n* No presence or history of significant neurological or psychiatric disorders\n* BDI-II ≥ 20, moderate depression\n* No presence or history of inflammatory or autoimmune disorders\n* Negative family history for neurodegenerative diseases\n* Cognitively healthy (i.e., education-adjusted MoCA total score ≥ 26 points at screening)\n* Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).\n* Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, or transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, or implantable\\], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).\n* Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.\n* Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.\n* Individuals must commit to not donating blood up to three months after the last PET scan.\n* Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal\u002Ffood intake).\n* Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.\n\nExclusion Criteria (all):\n\n* Unwilling and\u002For unable to cooperate with study procedures\n* Current or a recent (\\\u003C12 months) history of drug or alcohol abuse\u002Fdependence\n* BDI ≥ 20, moderate depression\n* Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood and urine testing\n* Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician\n* Recent (less than 30 days) use of antipsychotics and corticosteroids\n* Recent (less than 2 days) use of NSAIDs.\n* Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.\n* Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with \\[11C\\]PBR28 PET\n* Presence of neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions, signs of inflammation of the CNS\n* Presence of serology compatible with HIV, syphilis, SARS-CoV2, or viral hepatitis\n* History of autonomic dysfunction, previous vasovagal syncope or a positive tilt-test, and with bradycardia or use of medications causing bradycardia (e.g. beta-blockers)\n* Pregnancy or breastfeeding\n* Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes\n* History of cancer within the last 5 years, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer.\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable\n* Contraindication to arterial cannulation, such as history of bleedings, haemorrhage, etc.\n* Negative Allen's test (i.e. absence of collateral flow on hands on the test)\n* Recent (less than 30 days) infection or vaccination (e.g. flu, SARS-CoV2 etc.)\n* Concurrent participation to any clinical trial testing investigational drugs\n\nExclusion Criteria (Parkinson's disease patients):\n\n* Unwilling and\u002For unable to cooperate with study procedures\n* Current or recent history of drug or alcohol abuse\u002Fdependence\n* BDI ≥ 20, moderate depression\n* Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood or urine testing\n* Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician\n* Recent (less than 30 days) use of antipsychotics and corticosteroids.\n* Recent (less than 2 days) use of NSAIDs.\n* Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.\n* Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with \\[11C\\]PBR28 PET\n* Presence of other neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions, signs of inflammation of the CNS\n* History of autonomic dysfunction, previous vasovagal syncope or a positive tilt-test, and with bradycardia or use of medications causing bradycardia (e.g. beta-blockers)\n* Presence of serology compatible with HIV, syphilis, SARS-CoV2, or viral hepatitis\n* Pregnancy or breastfeeding\n* Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes\n* History of cancer within the last 5 years, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer.\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable\n* Contraindication to arterial cannulation, such as history of bleedings, haemorrhage, etc.\n* Negative Allen's test (i.e. absence of collateral flow on hands on the test)\n* Recent (less than 30 days) infection or vaccination (e.g. flu, SARS-CoV2 etc.)\n* Concurrent participation to any clinical trial testing investigational drugs\n\nExclusion criteria (for participants with iRBD):\n\n* Unwilling and\u002For unable to cooperate with study procedures\n* Current or a recent (\\\u003C12 months) history of drug or alcohol abuse\u002Fdependence\n* BDI-II ≥ 20, moderate depression\n* Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood and urine testing\n* Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician\n* Recent (less than 30 days) use of antipsychotics and corticosteroids\n* Recent (less than 2 days) use of NSAIDs.\n* Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: Ephedrine, ketamine, isoflurane, cocaine, methylphenidate, amphetamine of any amphetamine derivatives, mazindol, modafinil, benztropine, fentanyl, derivatives, buproprion, phentermine neuroleptics, metoclopramide, alpha methyldopa, , reserpine, .\n* Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with \\[11C\\]PBR28 PET\n* Presence of neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions, signs of inflammation of the CNS\n* Presence of serology compatible with HIV, syphilis, or viral hepatitis\n* History of autonomic dysfunction, previous vasovagal syncope or a positive tilt-test, and with bradycardia or use of medications causing bradycardia (e.g. beta-blockers)\n* Pregnancy or breastfeeding\n* Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes\n* History of cancer within the last 5 years, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer.\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable\n* Contraindication to arterial cannulation, such as history of bleedings, haemorrhage, etc.\n* Negative Allen's test (i.e. absence of collateral flow on hands on the test)\n* Recent (less than 30 days) infection or vaccination (e.g. flu, SARS-CoV2 etc.)\n* Evidence of presynaptic dopaminergic denervation on \\[123I\\]FP-CIT SPECT\n* Concurrent participation to any clinical trial testing investigational drugs",{"count":545,"type":22},30,"It is not known what causes Parkinson's disease and what makes it worsen over time. Research conducted in the past few years has highlighted the possible role of inflammation on this process but its actual mechanisms are still obscure.\n\nIn this study, the investigators aim to gain understanding on how inflammation is increased in Parkinson's disease and what are its mechanisms, by performing two Positron Emission Tomography (PET) scans using the tracer \\[11C\\]PBR28, that takes pictures of the brain highlighting the areas of inflammation, before and after the administration of a compound called Lipopolysaccharide or LPS, that is known to cause a mild degree of inflammation. The investigators will couple this study with two venous blood draws to measure the levels of circulating molecules of inflammation.",[30,142,548],"REM Sleep Behavior Disorder (iRBD)",[515,550,551,552],"Inflammation","Neuroimaging","Biomarkers",{"date":496,"type":65},{"date":555,"type":65},"2022-02-28",{"date":557,"type":22},"2026-08-31",{"name":502,"class":129},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":81,"sex":18,"minAge":566,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":573,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":590},"100496444","effects-of-long-term-ventilation-support-on-the-quality-of-life-of-als-patients-and-their-families-100496444","NCT05744310","Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families","ALS-LTMV","Inclusion criteria for patients:\n\n1. A clinical diagnosis of probable ALS according to the revised El Escorial criteria\n2. Progression of the illness leading the consulting physician to offer treatment with LTMV\n3. Can communicate in Norwegian\n\nInclusion criteria for partners of ALS patients:\n\n1. Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nInclusion criteria for children:\n\n1. Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nExclusion criteria for patients, partners and children of ALS patients:\n\n1\\. Potential participants with cognitive impairment or dementia.","8 Years",{"count":280,"type":22},[25],"Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality.\n\nThe present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.",[45,287,29,571,30,572],"Spinal Cord Diseases","TDP-43 Proteinopathies",[574,575,576,577,578,579,580],"Quality of life","Overall quality of life","Health related quality of life","Disease specific quality of life","Ventilation support","Non-invasive ventilation support","Invasive ventilation support","2025-08-22",{"date":583,"type":65},"2025-08-28",{"date":585,"type":65},"2023-04-21",{"date":587,"type":22},"2032-08-21",{"name":589,"class":129},"Haukeland University Hospital",9,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":81,"sex":18,"minAge":347,"maxAge":167,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":157},"100466736","phase-4-characterization-of-the-serotonin-2a-receptor-selective-pet-tracer-18fmhmz-in-patients-with-neurodegenerative-diseases-100466736","NCT05357612","Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases","Inclusion Criteria:\n\n* Patient arm - clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, and other variants\n* Healthy arm - age and gender matched to patient arm\n* Psychosis (presence of hallucinations or delusions) starting after the diagnosis of Parkinson's disease, occurring at least weekly for 4 weeks, severe enough to warrant treatment.\n* Study partner available for study visits\n\nExclusion Criteria:\n\n* Prior stroke or other uncontrolled serious neurological or medical illness\n* Contra-indication or inability to tolerate MRI scan\n* Use of serotonergic medications in the last 6 weeks\n* Incapable of providing independent consent.\n* Pregnant or breastfeeding women\n* psychosis due to a metabolic, toxic, or primary psychiatric disease\n* Deemed unable to complete neurocognitive testing\n* For PD Participants: current or prior use of pimavanserin\n* Use of antipsychotics in the last 2 weeks",{"count":598,"type":22},75,[600],"PHASE4","It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age\u002Fsex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\\[18F\\]MH.MZ in both populations.",[30,142,603],"Parkinson Disease Psychosis","2025-08-06",{"date":606,"type":65},"2025-08-12",{"date":608,"type":65},"2023-01-23",{"date":610,"type":22},"2026-08",{"name":612,"class":129},"Vanderbilt University Medical Center",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":81,"sex":18,"minAge":621,"maxAge":4,"enrollmentInfo":622,"targetDuration":623,"studyType":257,"phases":4,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":633,"locationsCount":157},"100602025","memory-deterioration-in-alzheimer-disease-100602025","NCT07118137","Memory Deterioration in Alzheimer Disease","Translational Neuroscience CAG for Alzheimer's Disease","MemAD","Inclusion Criteria:\n\n* Confirmed diagnosis based on current ICD criteria for AD or MCI .\n* \\>55years.\n* Norwegian native speaker\n* Lives at home and not in a health institution\n\nExclusion Criteria:\n\n* Patients with severe cognitive impairment that prevents assessment with the selected modalities (planned cut-off: CDR \\> 2).\n* Presence of brain tumors.\n* History of traumatic brain injury.\n* History of cranial surgery.\n* Contraindications to the selected imaging modalities (e.g., 7T MRI or EEG).\n* Diagnosis of other neurodegenerative diseases such as Parkinson's disease or ALS.\n\n  7T MRI contraindications:\n* Large tattoos close to the head region, permanent makeup or unremoveable piercings\n* Certain models of pacemakers (if pacemaker implantet, MRI physicist at 7T-lab will be conferred)\n* Implantet metal in body (clips, stents, prothesis, skrews, plates, teeth etc.)","55 Years",{"count":545,"type":22},"1 Year","Semantic AD",[48,30,626,627],"Magnetic Resonance Imaging","Memory Impairment","2025-08-04",{"date":606,"type":65},{"date":631,"type":65},"2023-10-15",{"date":446,"type":22},{"name":634,"class":129},"Norwegian University of Science and Technology",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":18,"minAge":643,"maxAge":4,"enrollmentInfo":644,"targetDuration":646,"studyType":257,"phases":4,"briefSummary":647,"conditions":648,"keywords":652,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":665},"100582886","saliva-and-extracellular-vesicles-for-neurodegenerative-diseases-100582886","NCT06869135","Saliva and Extracellular Vesicles for Neurodegenerative Diseases","Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling","MINERVA","Inclusion Criteria:\n\n* AD: standard criteria for dementia due to AD with AD neurochemical demonstration.\n* PD: MDS Criteria; modified Hoehn\\&Yahr stages; stable pharmacological treatment (last 4 weeks).\n* AtP: current consensus diagnostic criteria for progressive supranuclear palsy; corticobasal degeneration and multiple system atrophy.\n* prodromic PD: according to diagnostic criteria by Berg;\n* MCI: according to diagnostic criteria by Dubois and Albert.\n\nExclusion Criteria:\n\n* For all the experimental groups considered, subjects with concomitant chronic and \u002F or inflammatory diseases of the oral cavity, other systemic diseases, oncological or infectious diseases will be excluded.\n* Patients not able to provide written informed consent autonomously will be excluded.\n* For PD patients: Vascular, familiar and drug- induced parkinsonism, other known or suspected causes (metabolic, brain tumor etc) or any suggestive features of AtP; dementia with MoCA Test Correct Score\\\u003C15","45 Years",{"count":645,"type":22},242,"12 Months","Early diagnosis of Neurodegenerative diseases (NDDs) and accurate patient profiling are key goals needed to tailor prompt personalized therapeutic strategies that can significantly impact disease progression and patients' quality of life. The project will validate a novel, cost-effective and quick biophotonic-based method for early and differential diagnosis of NDDs (Parkinson's disease, atypical parkinsonisms, Alzheimer's disease) and for routine clinical monitoring of NDD progression (longitudinal study). Raman spectroscopy (RS) will be applied to biochemically profile saliva and salivaderived Extracellular Vesicles (sEVs) and to identify a spectroscopic biomarker for NDDs. Optimized protocols for RS will be used to concomitantly evaluate saliva and sEVs from people with NDDs and to detect salivary changes in the biochemical profile, with special focus on EV-associated components. The accuracy of the method in discriminating NDDs at different disease stages and during disease progression will be verified. A nanotechnology-based biomolecular characterization of saliva and sEV will clarify the involvement of specific pathological molecules in NDDs progression.",[30,142,48,649,650,651],"Parkinsonism","Mild Cognitive Impairment (MCI)","Prodromal Parkinson's Disease",[653,654,655,656],"Saliva","Raman Spectroscopy","Extracellular Vesicles","Diagnosis",{"date":658,"type":65},"2025-08-07",{"date":660,"type":65},"2025-01-24",{"date":662,"type":22},"2027-12-15",{"name":664,"class":129},"Fondazione Don Carlo Gnocchi Onlus",5,{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":81,"sex":18,"minAge":19,"maxAge":348,"enrollmentInfo":672,"targetDuration":673,"studyType":257,"phases":4,"briefSummary":674,"conditions":675,"keywords":678,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":73},"100571857","beta-amyloid-petct-in-various-a-related-disease-100571857","NCT06725706","Beta Amyloid PET\u002FCT in Various Aβ-Related Disease","Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET\u002FCT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.",{"count":21,"type":22},"7 Days","To evaluate the potential usefulness of 18F-92\u002FAV45, 11C-PIB positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.",[676,677,30],"Amyloid","Beta-Amyloid",[679,369,677],"PET\u002FCT","2025-06-03",{"date":682,"type":65},"2025-06-04",{"date":684,"type":65},"2012-09-01",{"date":686,"type":22},"2027-12-01",{"name":688,"class":129},"Tianjin Medical University",{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":695,"eligibilityCriteria":696,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":697,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":699,"conditions":700,"keywords":701,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":716},"100542155","neurofilament-light-chain-and-voice-acoustic-analyses-in-dementia-diagnosis-100542155","NCT06339190","Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis","A Blood Test for Dementia? A Cohort Study to Assess the Diagnostic Utility of Plasma Neurofilament Light Chain Protein in All-cause Dementia","NAVAIDD","Inclusion Criteria:\n\n* All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder\n\nExclusion Criteria:\n\n* Prognosis \\\u003C12 months\n* No cognitive complaint\n* Patients not involved within the single healthcare network",{"count":698,"type":22},1000,"This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.\n\nParticipants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.\n\nIndividuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.",[30,49],[702,49,703,704,60,705,706],"Alzheimer's disease","Neurofilament light chain","Speech","Biomarker","Health care disparity","2025-05-29",{"date":709,"type":65},"2025-05-30",{"date":711,"type":65},"2021-08-01",{"date":713,"type":22},"2027-12",{"name":715,"class":129},"Monash University",2,{"id":718,"slug":719,"hasResults":12,"nctId":720,"briefTitle":721,"officialTitle":721,"acronym":722,"eligibilityCriteria":723,"healthyVolunteers":12,"sex":18,"minAge":347,"maxAge":4,"enrollmentInfo":724,"targetDuration":4,"studyType":23,"phases":726,"briefSummary":727,"conditions":728,"keywords":730,"overallStatus":261,"whyStopped":4,"lastUpdateSubmitDate":744,"lastUpdatePostDateStruct":745,"startDateStruct":746,"completionDateStruct":748,"leadSponsor":750,"locationsCount":716},"100592416","slow-speed-slowing-parkinsons-early-through-exercise-dosage-100592416","NCT06993142","Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage","Slow-SPEED","Inclusion criteria\n\n1. previously identified LRRK2 G2019S or GBA N370S variant based on genotyping\n2. aged 50 years or older\n3. able to understand the English language\n4. being able to walk independently inside the home without the use of a walking aid\n5. in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer)\n6. Not in a high physical activity range during the 4-week eligibility and baseline period\n\nExclusion criteria\n\n1. clinically diagnosed or self-reported diagnosis neurodegenerative disease\n2. self-reported falls of three or more per year\n3. dexterity problems or cognitive impairments hampering smartphone use\n4. if they are not aware of and do not wish to be informed about an increased risk of developing diseases associated with the LRRK2 or GBA1 risk variant\n5. if individual is not community-dwelling\n6. in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)",{"count":725,"type":22},600,[25],"The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation.\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, the investigators aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[142,354,30,355,175,356,29,357,174,358,729],"Genetic Predisposition",[731,732,733,734,735,736,469,737,738,142,739,740,741,742,743],"Physical activity","Prevention","Remote","Mobile Health (mHealth)","Feasibility","Exercise","Motivational application","Walking","Prodromal","LRRK2","GBA1","Genetic","Smartwatch","2025-05-28",{"date":680,"type":65},{"date":747,"type":22},"2025-07-01",{"date":749,"type":22},"2029-06-30",{"name":751,"class":129},"Radboud University Medical Center",{"id":753,"slug":754,"hasResults":12,"nctId":755,"briefTitle":756,"officialTitle":756,"acronym":757,"eligibilityCriteria":758,"healthyVolunteers":12,"sex":18,"minAge":347,"maxAge":4,"enrollmentInfo":759,"targetDuration":4,"studyType":23,"phases":761,"briefSummary":762,"conditions":763,"keywords":765,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":744,"lastUpdatePostDateStruct":769,"startDateStruct":770,"completionDateStruct":772,"leadSponsor":773,"locationsCount":157},"100530935","slow-speed-nl-slowing-parkinsons-early-through-exercise-dosage-netherlands-100530935","NCT06193252","Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands","Slow-SPEED-NL","Inclusion Criteria:\n\n* previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)\n* able to understand the Dutch language\n* being able to walk independently inside the home without the use of a walking aid\n* Not in a high physical activity range during the 4-week eligibility and baseline period\n* in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.\n\nExclusion Criteria:\n\n* clinically diagnosed or self-reported diagnosis neurodegenerative disease;\n* self-reported weekly falls in the previous 3 months;\n* dexterity problems or cognitive impairments hampering smartphone use;\n* if they do not wish to be informed about an increased risk of developing diseases associated with iRBD\n* if individual is not community-dwelling\n\nExclusion criteria for MRI only:\n\n* history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery\n* claustrophobia\n* implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)\n* metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters\n* pregnancy\n* fear for incidental finding",{"count":760,"type":22},110,[25],"The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months).\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[142,354,30,358,764,355,175,356,29,357,174],"REM Sleep Behavior Disorder",[766,732,733,734,735,736,469,767,768,369,737,738,142,739],"Physical Activity","Blood","Imaging",{"date":680,"type":65},{"date":771,"type":65},"2024-01-15",{"date":686,"type":22},{"name":751,"class":129},{"id":775,"slug":776,"hasResults":12,"nctId":777,"briefTitle":778,"officialTitle":779,"acronym":780,"eligibilityCriteria":781,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":782,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":784,"conditions":785,"keywords":787,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":794,"lastUpdatePostDateStruct":795,"startDateStruct":797,"completionDateStruct":799,"leadSponsor":800,"locationsCount":802},"100416712","systematic-assessment-of-laryngopharyngeal-function-in-patients-with-neurodegenerative-diseases-100416712","NCT04706234","Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases","Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases","FEEMSA","Inclusion Criteria:\n\n* diagnosis of probable or possible multiple system atrophy according to current consensus criteria (Gilman et al. 2008) or\n* diagnosis of probable or possible PSP according to the the Movement Disorders Society (MDS) diagnostic criteria (Höglinger et al. 2017) or\n* diagnosis of Parkinson's disease according to the MDS diagnostic criteria (Postuma et al 2015)\n* Hoehn and Yahr Stage within the range of I-V or\n* diagnosis of motor neurone disease or\n* diagnosis of a neurodegenerative disease other than specified above\n\nAND underwent laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).\n\nExclusion Criteria:\n\n\\- Patients who do not sign the consent form",{"count":783,"type":22},350,"This is a non-interventional observational study designed to systematically record the results of routine laryngeal examinations and specific characteristics of dysphagia in patients with neurodegenerative disorders. The results of a fiberoptic \u002F flexible endoscopic evaluation of swallowing (FEES) while performing a structured task protocol will be recorded. If available, laryngeal electromyography (EMG) results will also be recorded. In addition to the examination results, demographic and disease-specific data are collected, and two questionnaires, the Swallowing Disturbance Questionnaire for Parkinson's Disease (SDQ-PD) and the swallowing specific Quality Of Life Questionnaire (SWALQOL), are administered.",[786,142,43,287,30],"Multiple System Atrophy",[786,43,788,287,30,789,790,791,792,793],"Parkinson's disease","Dysphagia","FEES","Laryngeal EMG","Irregular Arytenoid Cartilages Movements","Clinical Biomarker","2025-04-07",{"date":796,"type":65},"2025-04-09",{"date":798,"type":65},"2017-09-01",{"date":69,"type":22},{"name":801,"class":129},"Kliniken Beelitz GmbH",16]