[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synucleinopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synucleinopathies":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,53,89,131,181,220,243,265,314],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100642012","phase-2-a-study-of-donanemab-ly3002813-in-participants-with-early-cognitive-decline-trailblazer-alz-7-100642012",false,"NCT07589595","A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)","A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology","Inclusion Criteria:\n\n* Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.\n* Have least 1 core clinical feature of dementia with Lewy bodies (DLB).\n* Have a score ≥20 on Montreal Cognitive Assessment (MoCA).\n* Meet plasma P-tau217 criteria.\n* Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.\n* Have a CSF result consistent with the presence of alpha-synuclein pathology.\n* Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n\nExclusion Criteria:\n\n* Have a disease or condition that could interfere with this study or is a current serious or unstable illness.\n* Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.\n* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.\n* Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.\n* Have previously received amyloid-targeting therapy.\n* Active immunization against amyloid-beta.\n* Have a centrally read MRI that does not meet study entry criteria.\n* Have contraindication to MRI or PET scans.\n* Have any contraindication to lumbar puncture.","ALL","55 Years","85 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.",[27,28,29,30],"Cognitive Dysfunction","Lewy Body Disease","Synucleinopathies","Amyloid",[32,33,34,35,36,37,38,39,27],"Mild Cognitive Impairment","Mild Dementia","Brain Diseases","Nervous System Diseases","Neurodegenerative Diseases","Neurocognitive Disorders","Cognition Disorders","Alzheimer Disease","RECRUITING","2026-06-16",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":44},"2026-05-20",{"date":48,"type":21},"2028-08",{"name":50,"class":51},"Eli Lilly and Company","INDUSTRY",72,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100607383","study-of-axial-and-cognitive-symptoms-and-biomarkers-of-neurodegeneration-in-brain-first-and-body-first-pd-100607383","NCT07187843","Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD","Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes","BRABOAXPD","Inclusion Criteria:\n\n* Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \\[123I-MIBG\\].\n* Free and informed consent expressed by the participant.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Inability to express free and informed consent.\n* Patient with a doubtful diagnosis.\n* Participant under 18 years of age.","18 Years",{"count":63,"type":21},150,"OBSERVATIONAL","This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed \"Brain-First\" and \"Body-First\" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.\n\nFindings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.",[67,68,69,70,29],"Parkinson Disease","Parkinsonian Disorders","Brain Disease","Basal Ganglia Diseases",[36,35,72,73,74,75,76,77],"Movement Disorders","biomarker","neuroinflammation","brain-first","body-first","axial symptoms","2026-04-22",{"date":80,"type":44},"2026-04-23",{"date":82,"type":44},"2024-09-04",{"date":84,"type":21},"2031-05",{"name":86,"class":87},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":88},"100633985","the-swedish-biofinder-sleep-study-100633985","NCT07533799","The Swedish BioFINDER Sleep Study","BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease","Inclusion Criteria:\n\nIdiopathic RBD:\n\n* Polysomnography verified RBD according to AASM criteria.\n* Does not fulfill diagnostic criteria for idiopathic Parkinson´s disease.\n* Age range 50-100. Women who are \\\u003C55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.\n* Ability to give informed consent.\n* Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.\n\nEarly Parkinson´s disease:\n\n* Fulfills the diagnostic criteria for idiopathic Parkinson´s disease.\n* The PD patients will be de novo (yet without any PD treatment) or with treatment for a maximum of 3 years.\n* Age range 50-100. Women who are \\\u003C55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.\n* Ability to give informed consent.\n* Speaks Swedish fluently as stated above. Healthy Controls\n* Age range 50-100. Women who are \\\u003C55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.\n* No diagnosis of PD or another significant neurological disorder.\n* No diagnosis of RBD.\n* Ability to give informed consent.\n* Speaks Swedish fluently as stated above.\n\nExclusion Criteria:\n\nFor all groups:\n\n* Past history of severe or repeated concussive head injury or stroke or any significant systemic disease or unstable medical condition.\n* History of severe and unstable depression, schizophrenia, schizoaffective disorder or bipolar disorder.\n* Significant white matter microvascular disease.\n* Contraindication to MRI and PET.\n\nExclusion criteria specific for early Parkinson´s disease:\n\n* Normal dopamine transporter (\\[18F\\]FE-PE2I) scan.",true,"50 Years","100 Years",{"count":100,"type":21},650,"BioFINDER-Sleep study was established in 2021 and will include patients with early Parkinson´s disease (PD) and persons with iRBD to provide essential insights into the underlying mechanisms of the progressive neurodegenerative processes in central and peripheral nervous systems. Briefly polysomnography will be used to establish the presence of RBD in both the early PD cohort and in the iRBD cohort. Then, state of the art multimodal imaging techniques will be used, including, magnetic resonance imaging (MRI), positron emission tomography (PET) of the dopamine transporters (DAT-PET) to quantify dopamine terminal loss, and \\[123I\\] MIBG scintigraphy of the heart will be performed to quantify the loss noradrenaline terminals to the heart. In addition to this, synuclein seed amplification assays (SSAs) will be applied to cerebrospinal fluid (CSF) and skin samples to establish synuclein pathology status. Further, CSF and blood biomarkers will be developed that can be used to as prognostic markers. These investigations will be done in parallel to clinical assessments of motor and non-motor symptoms as well as assessment of cognitive function in a longitudinal setting.",[103,104,28,105,29],"Parkinson´s Disease","REM Sleep Behavior Disorder (iRBD)","Synucleinopathy",[107,108,109,110,111,112,113,114,115,116,117,118,119,120],"Early diagnosis","CSF","Plasma","PET","MRI","DAT PET","Smell test","synuclein seed amplification assays","MIBG","Polysomnography","α-synuclein","Motoric test","cognitive test","UPDRS","2026-04-09",{"date":123,"type":44},"2026-04-16",{"date":125,"type":44},"2021-10-01",{"date":127,"type":21},"2033-06",{"name":129,"class":130},"Skane University Hospital","OTHER",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":96,"sex":16,"minAge":97,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":88},"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","80 Years",{"count":140,"type":21},130,[142],"NA","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.",[67,145,36,70,146,29,35,147,34,68],"Prodromal Stage","Central Nervous System Diseases","Cerebral Disorder",[149,150,151,152,153,154,73,155,156,111,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171],"intervention","movement","iRBD","prodromal parkinson's","non-pharmacologic","alpha-synucleinopathy","cognitive decline","executive function","lifestyle","prevention","RCT","motor decline","smartphone","smartwatch","accelerometer","scalable","prodromal","PD","Parkinson","Lewy-body","MSA","multiple system atrophy","dementia","2026-01-14",{"date":174,"type":44},"2026-01-16",{"date":176,"type":44},"2025-12-04",{"date":178,"type":21},"2029-12-01",{"name":180,"class":130},"University Hospital, Bonn",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"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":189,"type":21},600,[142],"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",[67,145,36,70,146,29,35,147,34,68,193],"Genetic Predisposition",[195,196,197,198,199,200,201,202,203,67,204,205,206,207,208],"Physical activity","Prevention","Remote","Mobile Health (mHealth)","Feasibility","Exercise","Digital biomarker","Motivational application","Walking","Prodromal","LRRK2","GBA1","Genetic","Smartwatch","NOT_YET_RECRUITING","2025-05-28",{"date":212,"type":44},"2025-06-03",{"date":214,"type":21},"2025-07-01",{"date":216,"type":21},"2029-06-30",{"name":218,"class":130},"Radboud University Medical Center",2,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":88},"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":228,"type":21},110,[142],"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",[67,145,36,68,232,70,146,29,35,147,34],"REM Sleep Behavior Disorder",[234,196,197,198,199,200,201,235,236,111,202,203,67,204],"Physical Activity","Blood","Imaging",{"date":212,"type":44},{"date":239,"type":44},"2024-01-15",{"date":241,"type":21},"2027-12-01",{"name":218,"class":130},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":96,"sex":16,"minAge":61,"maxAge":138,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":88},"100579709","early-phase-1-application-of-18f-cp6a-pet-imaging-in-synucleinopathies-100579709","NCT06827821","Application of 18F-CP6A PET Imaging in Synucleinopathies","Preliminary Evaluation of the Safety, Pharmacokinetics, and Clinical Application of 18F-CP6A PET Imaging in Synucleinopathies","Inclusion Criteria:\n\nHealthy Volunteers:\n\n1. Fully understand and voluntarily sign the informed consent form.\n2. Aged 18-65 years, any gender.\n3. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; BMI within 19.0-26.0 kg\u002Fm2.\n4. Non-synucleinopathy, normal motor function, UPDRS score of 0.\n5. No history of other neurological or chronic diseases in the last 3 years.\n6. No abnormal vital signs or physical examination findings.\n7. No pregnancy or lactation, and willing to use effective contraception during the trial period and for 6 months post-study.\n8. No participation in other clinical trials within the past month.\n9. Able to communicate effectively with the study team and understand and comply with the study requirements.\n\nSynucleinopathy Patients:\n\n1. Ability to sign the informed consent form or by a legal representative.\n2. Aged 50-80 years, any gender.\n3. Clinically diagnosed or suspected PD, MSA, or DLB based on diagnostic criteria \\[including China's Parkinson's Disease Diagnosis (2016), MSA Consensus (2022), and DLB Guidelines (2021)\\].\n4. No other neurological diseases, severe chronic diseases, or malignancies.\n5. No family history of neurodegenerative diseases or movement disorders.\n6. Female participants of childbearing potential must use contraception throughout the study period.\n\nExclusion Criteria:\n\nHealthy Volunteers:\n\n1. Any severe or unstable medical condition, acute diseases prior to the study.\n2. Pregnant or breastfeeding women.\n3. Any surgery within the last 6 months that could affect drug absorption, distribution, metabolism, or excretion.\n4. Use of any medication (prescription or over-the-counter) within 2 weeks prior to the study.\n5. Inability to undergo PET\u002FMRI or PET\u002FCT imaging (e.g., claustrophobia).\n6. Participation in studies involving radioactive substances within the last 12 months.\n7. Any other factor that may interfere with study results.\n\nSynucleinopathy Patients:\n\n1. Inability or unwillingness to sign the informed consent form.\n2. Pregnant or breastfeeding participants.\n3. History of other neurological diseases or severe chronic illnesses.\n4. Known allergy to α-Syn imaging agents or synthetic excipients.\n5. Inability to complete PET\u002FMR or PET\u002FCT imaging.\n6. Researcher assesses poor compliance or other conditions that would render participation unsuitable.\n7. Major surgery within the last month.\n8. Participation in other clinical trials within the last 3 months.",{"count":251,"type":21},18,[253],"EARLY_PHASE1","Synucleinopathies are a group of severe neurodegenerative diseases, including Parkinson's Disease (PD), Dementia with Lewy Bodies (DLB), and Multiple System Atrophy (MSA). A common feature of these diseases is the pathological aggregation of α-synuclein (α-Syn), which forms Lewy Bodies (LBs), directly causing neuronal damage and death. Clinically, these diseases can present similar parkinsonian syndromes, making differential diagnosis more challenging. However, they may exhibit significant differences in the distribution and morphology of α-Syn pathology. For example, in MSA, the pathological α-Syn primarily accumulates in oligodendrocytes, particularly in the brainstem and cerebellar white matter, which differs significantly from the neuronal Lewy Body formation seen in PD and DLB.\n\nCurrently, imaging biomarkers related to β-amyloid (Aβ) and tau proteins have been widely used in clinical diagnosis and research. However, imaging biomarkers targeting α-Syn are still relatively lacking, which limits the early diagnosis and accurate subtyping of these diseases.\n\nIn recent years, some PET imaging agents targeting α-Syn have demonstrated good affinity in vitro and in animal experiments, significantly outperforming other common neurodegenerative biomarkers, including Aβ and tau proteins. These agents show promising potential in aiding the diagnosis of synucleinopathies. Professor Ye Keqiang's team at Shenzhen University of Technology has previously developed a small molecule compound (F0502B) with high affinity and selectivity for α-Syn aggregates. Early in vivo and in vitro experiments showed that it could specifically bind to LBs and quantify the amount of LBs in the brain, aiding the early detection of preclinical PD patients and dynamic monitoring of disease progression. Further optimization of the F0502B compound led to the development of its derivative, CP6A. The 18F-labeled probe of CP6A preferentially highlights α-Syn deposition in the brains of animal models and has demonstrated good safety in both mice and monkeys.\n\nBased on the above, this project intends to include clinically diagnosed or highly probable synucleinopathy patients and healthy volunteers, using the 18F-labeled derivative of the α-synuclein-specific imaging agent, 18F-CP6A, to perform integrated PET imaging. The goal is to explore the in vivo safety, pharmacokinetics, and clinical application value of 18F-CP6A in synucleinopathies.",[29],"2025-02-10",{"date":258,"type":44},"2025-02-14",{"date":260,"type":21},"2025-02-17",{"date":262,"type":21},"2026-12-31",{"name":264,"class":130},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":273,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":275,"conditions":276,"keywords":289,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":88},"100561944","neurodegenerative-diseases-progression-markers-markers-ndd-100561944","NCT06596746","Neurodegenerative Diseases Progression Markers (MARKERS-NDD)","Neurodegenerative Diseases Progression Markers (MARKERS-NDD): a Real-world Data Longitudinal Prospective Study","MARKERS-NDD","Inclusion Criteria:\n\n* Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders\n\n  * Patients with diagnosis of Parkinson's Disease\n\n    * Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank\n  * Diagnosis of Movement Disorder not related to Parkinson's Disease\n\n    * Diagnosis of Multiple System Atrophy (MSA) in accordance with Second Consensus Statement on Diagnosis of Multiple System Atrophy;\n    * Diagnosis of Progressive Supranuclear Palsy according to Movement Disorder Society for Diagnosis of Progressive Supranuclear Palsy;\n    * Diagnosis of Essential Tremor\n    * Willing to participate in the study, understand the procedures and sign the informed consent.\n* Patients affected by cognitive impairment (CI) and dementia\n\n  * Diagnosis of probable:\n\n    * Lewy Body Dementia\n    * Alzheimer's Disease\n    * Mild Cognitive Decline\n    * Subjective memory complaints\n    * Willing to participate in the study, understand the procedures and sign the informed consent.\n\nExclusion Criteria:\n\n* There are no restrictions for participation in the study based on age, severity of illness or presence of cognitive impairment, as long as the person is able to complete the research assessments.","10 Years",{"count":189,"type":21},"MARKERS-NDD is a prospective, observational, longitudinal study, which aims to collect data from patients affected by neurodegenerative diseases (NDD) followed longitudinally for routine examinations performed as part of normal clinical practice. Data collected from clinical evaluations, movement analysis, brain imaging, neuropsychological and electroencephalographic assessments, blood chemistry tests will be analysed to carry out statistical investigations and predictive analyses, also using artificial intelligence systems, which allow the identification of new early markers of diagnosis and prognosis of neurodegenerative diseases.",[36,67,29,28,277,278,39,279,280,281,282,283,284,72,285,286,287,288],"Multiple System Atrophy","Tauopathies","Corticobasal Degeneration","Supranuclear Palsy, Progressive","Atypical Parkinsonism","TDP-43 Proteinopathies","Amyotrophic Lateral Sclerosis","Frontotemporal Lobar Degeneration","Cognitive Impairment","Dementia","Iron Overload","Neurodegeneration With Brain Iron Accumulation (NBIA)",[36,290,291,292,293,294,295,296,297,298,299,300,301,302,303],"Markers","Gait analysis","Wearable inertial sensors","IMU","Artificial intelligence","AI-Video gait analysis","Handwriting analysis","Voice-based artificial intelligence systems","imaging","multimodal analysis","electroencephalogram","cortical activity","gut microbiota","laboratory blood chemistry parameters","2024-09-11",{"date":306,"type":44},"2024-09-19",{"date":308,"type":21},"2024-09-09",{"date":310,"type":21},"2034-09-09",{"name":312,"class":313},"Casa di Cura San Raffaele Cassino","NETWORK",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":96,"sex":16,"minAge":61,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":323,"conditions":324,"keywords":337,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100557135","digital-diagnostics-and-intervention-services-for-parkinsons-disease-100557135","NCT06534177","Digital Diagnostics and Intervention Services for Parkinson's Disease","Development of Digital Diagnostics and Intervention Services for Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \\[stroke, multiple sclerosis, arthritis or osteoporosis\\]\n* Able to self-report history of daily gait freezing and\u002For festination for people with PD or gait and\u002For transfers affected by condition\n* Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands Healthy participants \\[Phase 1,2,3\\]\n* With no long-term conditions affecting movement\n* Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and\n* if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands\n\nExclusion Criteria:\n\n* Participants with long-term conditions affecting movement\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system Healthy participants\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system",{"count":322,"type":21},80,"People with Parkinson's have infrequent clinical consultation (once every 12-18 months) and limited rehabilitation.\n\nAssessment play an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes. There is a strong need for more frequent and accurate Parkinson's assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly. There is a need to develop good home digital physiotherapy tools to increase the amount of therapy. Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home. The investigators aim to conduct a clinical study with 50 people with Parkinson's (50 from UK) with the UPDRS, (a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinson's disease) and 30 healthy adults. The investigators will develop and investigate if two new digital devices, one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS (motor) using digital gait and ophthalmic features in the clinic setting. The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home. The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community",[34,146,35,325,326,67,70,72,29,327,328,329,330,331,332,333,334,335,336],"Joint Diseases","Musculoskeletal Diseases","Neuro-Degenerative Disease","Demyelinating Disease, Autoimmune, CNS","Demyelinating Disease","Autoimmune Diseases","Immune System Diseases","Bone Diseases, Metabolic","Bone Diseases","Arthritis","Osteoporosis","Multiple Sclerosis",[338,339,340,341,342],"parkinson's disease","osteoarthritis","stroke","MS","osteoporosis","2024-08-06",{"date":345,"type":44},"2024-08-09",{"date":347,"type":21},"2024-10-15",{"date":349,"type":21},"2026-03-01",{"name":351,"class":130},"University of Exeter"]