[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dementia-with-lewy-bodies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dementia-with-lewy-bodies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,49,79,111,136,158,185,207,249,280,310,330,351,372,400,421,463,486,511],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640941","evaluating-how-red-light-therapy-applied-to-the-head-affects-symptoms-daily-life-and-brain-activity-in-people-with-dementia-with-lewy-bodies-100640941",false,"NCT07602296","Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies","Effect of Transcranial Photobiomodulation on Clinical Symptoms, Quality of Life and Cerebral Connectivity Modifications in Dementia With Lewy Bodies","LewyLIGHT","Inclusion criteria:\n\n* Man or woman, 50 years or older\n* Probable DLB diagnosed according to the criteria of McKeith et al., 2017, or the criteria of McKeith et al., 2020 for prodromal DLB\n* Score on the Mini Mental State Examination (MMSE; Folstein et al., 1983) ≥ 18\u002F30 at their last medical visit\n* Good mastery of the French language\n* Accompanied by a caregiver or a person able to provide information about them (interview, by telephone).\n* Able to understand the objectives and risks associated with the research and to give informed consent, dated and signed\n* Covered by a social health insurance plan\n* Having a head circumference between 54 and 62 cm.\n\nExclusion criteria:\n\n* Not able to understand the objectives and risks related to research and to give informed consent\n* Presence of another neurological disorder, including but not limited to brain tumors, stroke with potential cognitive impairment, or diagnosis of another progressive neurological disease (e.g., Alzheimer's disease, Parkinson's disease, etc.), and as determined by the investigator\n* Having an MMSE score \\\u003C 18 at the screening visit\n* Unable to undergo a brain MRI due to medical reasons\n* Participants whose follow-up would likely be disrupted during the study period (e.g., due to planned relocation or other reasons)\n* Insufficient proficiency of the French language\n* Participants experiencing an emergency of life-threatening situation\n* Alone, without a caregiver present\n* Participants presenting with a head\u002Fscalp injury\n* Participants with a silicone allergy\n* Participants with cranial\u002Fskull shape abnormalities\n* Participants with a head circumference outside the range of 54-62 cm\n* Participants requiring life support, continuous monitoring, and\u002For implanted medical devices (AIMD)\n* Participants taking the antiepileptic Keppra (Levetiracetam)\n* Participants whose anticholinesterase treatments have been changed within the past 2 months\n* Participants whose antipsychotic treatments have been changed within the last 15 days\n* Pregnant or breastfeeding women","ALL","50 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Dementia with Lewy bodies (DLB) is a neurodegenerative disease diagnosed primarily based on the presence of cognitive decline, which may include difficulties with memory, attention, and more. Additionally, at least two of the following symptoms are needed for a probable diagnosis of DLB, and at least one for a possible DLB diagnosis (McKeith et al. 2017 and 2020):\n\n* Fluctuations in cognition, attention, and\u002For alertness\n* Visual hallucinations\n* Spontaneous parkinsonism\n* REM sleep behavior disorder\n\nPatients with DLB can experience cognitive deficits that can fluctuate and can vary for each patient. These may include deficits in memory, executive functions (planning and organizing), attention, visual processing, and language.\n\nThis study aims to evaluate the effect of red-light therapy, delivered using a helmet that contains small LED lights, in patients with DLB.\n\nParticipants' cognitive functions, clinical symptoms, quality of life and functional cerebral connectivity will be evaluated before starting therapy and again after three and six months of twice daily therapy use. As DLB also indirectly affects caregivers, the caregiver's quality of life and burden will also be evaluated before and at three and six months of therapy use by the participant.\n\nThe study's inclusion period is 24 months and the duration of participation for each patient is 8 months (+\u002F-10 days) maximum.",[27,28],"Photobiomodulation","Dementia With Lewy Bodies",[30,31,32,33,34,35],"Photobiomodulation (PBM)","Dementia with Lewy bodies (DLB)","Cognitive functions","Clinical symptoms","Quality of life","Cerebral connectivity","NOT_YET_RECRUITING","2026-06-18",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":21},"2026-06",{"date":44,"type":21},"2029-03",{"name":46,"class":47},"University Hospital, Strasbourg, France","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100193894","natural-history-study-of-synucleinopathies-100193894","NCT01799915","Natural History Study of Synucleinopathies","Inclusion Criteria:\n\n1. Both male and female patients will be included\n2. Aged 18 or over\n3. Referred to any of the participating consortium sites with orthostatic intolerance, defined as symptoms of dizziness or lightheadedness in the standing position that disappear when supine.\n\nExclusion Criteria:\n\n1. Diabetes according to the American Diabetes Association criteria\n2. Congestive heart failure\n3. Lupus or other collagen vascular disease\n4. Systemic illness thought to be responsible for the orthostatic intolerance\n5. Drug-induced orthostatic hypotension (i.e., the use of alpha-blockers, diuretics, tricyclic antidepressants or others thought by the investigator to play an important role in the patient's orthostatic hypotension)\n6. Isolated vasovagal syncope\n7. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.","18 Years",{"count":57,"type":21},800,"OBSERVATIONAL","Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA).\n\nHowever, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This \"pre-motor\" autonomic stage suggests that the disease process may not yet have spread to the brain.\n\nAfter a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease.\n\nThe purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD\u002FDLB and MSA) and those believed to be in the \"pre-motor\" stage (with isolated autonomic impairment and\u002For RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor\u002Fcognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.",[61,62,63,64,65,28,66,67],"Patients With Synucleinopathies","Neurogenic Orthostatic Hypotension","Pure Autonomic Failure","REM Sleep Behavior Disorder","Parkinson Disease","Multiple System Atrophy","Shy-Drager Disease","RECRUITING","2026-06-09",{"date":71,"type":40},"2026-06-10",{"date":73,"type":40},"2011-06",{"date":75,"type":21},"2026-12-30",{"name":77,"class":47},"NYU Langone Health",8,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":78},"100407658","phase-2-ambroxol-in-new-and-early-dlb-a-phase-iia-multicentre-randomized-controlled-double-blind-clinical-trial-100407658","NCT04588285","Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial","A Clinical Trial to Demonstrate Clinical Efficacy on Cognitive, Neuropsychiatric and Functional Outcomes of Ambroxol in New and Early Patients With Prodromal and Mild Dementia With Lewybodies","ANeED","Inclusion Criteria:\n\n1. Male or female.\n2. Age ≥ 50 and ≤ 85 years of age.\n3. Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).\n4. MMSE score\\>=15\n5. Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1.\n6. Capable of complying with all study procedures.\n7. Willing to provide blood samples for genetic analyses of APOE and GBA.\n8. Willing and able to self-administer or administer by a caregiver oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)).\n9. Able to travel to the participating study site.\n10. A female participant is eligible to participate if she is of:\n\n    Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 - 134.8 IU\u002FL and oestradiol \\\u003C 201 pmol\u002Fl at entry.\n\n    Women of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.\n11. A female participant is eligible to participate if she is of:\n\nNon-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 - 134.8 IU\u002FL and oestradiol \\\u003C 201 pmol\u002Fl at entry.\n\nWomen of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.\n\nExclusion Criteria:\n\n1. Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.\n2. Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.\n3. Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study;\n4. Confirmed dysphagia that would preclude self-administration of ambroxol up to 6 tablets daily for the duration of day 1 to day 550\u002FMonth 18.\n5. Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.\n6. History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, copovidone and magnesium stearate) in the opinion of the investigator that contraindicates their participation.\n7. History of known rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.\n8. History of illegal substance abuse, drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the study.\n9. Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of the study drug.\n10. Pregnant or breastfeeding; All participants of child bearing potential in the opinion of the Investigator that would preclude participation in the study and who do not agree to use double-barrier birth control or abstinence while participating in the study and for two weeks following the last dose of study drug;\n11. Any clinically significant or unstable psychiatric, medical or surgical condition that in the opinion of the PI or PI-delegated clinician may put the participant at risk when participating in the study or may influence the results of the study or affect the participant's ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests.\n\n    Such conditions may include:\n    1. Impaired renal function\n    2. Moderate\u002FSevere hepatic impairment\n    3. A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, pulmonary embolism, coronary revascularisation that occurred within 6 months prior to the screening visit.\n    4. Major depression, delirium or psychosis not related to DLB.\n    5. Metastatic cancer or terminal illness.\n12. Planned major surgery or other major treatments during study period that will interfere with study-obligations.","85 Years",{"count":89,"type":21},180,[91],"PHASE2","This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).",[28],[95,96,97,98,99,100,101],"Cognitive","Neuropsychiatric","Functional Outcomes","New and Early Patients","Prodromal","Mild Dementia","Lewybodies","2026-04-29",{"date":104,"type":40},"2026-05-05",{"date":106,"type":40},"2021-05-04",{"date":108,"type":21},"2027-09-15",{"name":110,"class":47},"Helse Fonna",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":48},"100381425","phase-1-18ff-dopa-imaging-in-patients-with-autonomic-failure-100381425","NCT04246437","[18F]F-DOPA Imaging in Patients With Autonomic Failure","Inclusion Criteria:\n\n1. Patients with a diagnosis if pure autonomic failure\n2. Patients with autonomic failure and possible PD, MSA, or DLB\n3. Healthy adults aged 18 and above\n4. Clinical exam confirming clinical designation\n\nExclusion Criteria:\n\n* Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction.\n* Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.\n* Subjects who have cerebral aneurysm clips.\n* Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).\n* Subjects who are pregnant, because the effects of high field MRI on fetuses are not yet known.\n* Minors (younger than 18 years)\n\nAlso excluded are subjects incapable of giving informed written consent:\n\n* Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.\n* Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.\n* Prisoners",true,{"count":20,"type":21},[120],"PHASE1","Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and\u002For glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. \\[18F\\]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease.",[123,63,65,66,28],"Autonomic Failure",[125,126],"FDOPA","PET","2026-03-12",{"date":129,"type":40},"2026-03-16",{"date":131,"type":40},"2020-02-04",{"date":133,"type":21},"2027-02-01",{"name":135,"class":47},"Daniel Claassen",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":48},"100420907","phase-1-terazosin-for-dementia-with-lewy-bodies-100420907","NCT04760860","Terazosin for Dementia With Lewy Bodies","a Randomized, Double Blind, Placebo Controlled Clinical Trial Exploring the Target Engagement and Tolerability of Terazosin Hydrochloride in Patients With Dementia With Lewy Bodies","TZ-DLB","Inclusion Criteria:\n\n* Men or women with the diagnosis of dementia with Lewy Bodies per 2017 DLB Consortium criteria.\n* Baseline MOCA 18 or above. On stable AChEI and\u002For memantine treatment regimen for ≥4 weeks prior to baseline.\n\nExclusion Criteria:\n\n* Subjects unwilling or unable to give informed consent\n* No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days.\n* Orthostatic hypotension defined as symptomatic decrease in BP \\> 20mmHg systolic or \\> 10mmHg diastolic on supine to sitting or standing, or a sitting blood pressure of ≤90\u002F60.\n* Clinically significant traumatic brain injury or post-traumatic stress disorder\n* Presence of other known medical comorbidities that in the investigator's opinion would compromise participation in the study\n* Psychiatric comorbidities including major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neurology assessment in the opinion of the responsible site principal investigator. Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit. Current suicidal ideation within one year prior to the baseline visit as evidenced by answering \"yes\" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit.\n* Use of investigational drugs within 30 days before screening\n* Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit\n* Use of doxazosin, alfuzosin, prazosin, or tamsulosin\n* For female participant, pregnancy, or plans for child-bearing during study period\n* Participant is restricted from traveling to and from the study site","0 Years","90 Years",{"count":20,"type":21},[120,91],"The TZ-DLB trial will be a 3:2 (active:placebo) randomized, double-blind, placebo-controlled Pilot trial to evaluate the tolerability of terazosin for the treatment of dementia with Lewy bodies.",[28],"2026-03-10",{"date":127,"type":40},{"date":153,"type":21},"2027-10",{"date":155,"type":21},"2030-12",{"name":157,"class":47},"Qiang Zhang",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":117,"sex":17,"minAge":18,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":48},"100614799","phase-4-elucidating-the-role-of-cholinergic-degeneration-in-cognitive-fluctuations-in-lewy-body-dementia-100614799","NCT07284290","Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia","Inclusion Criteria:\n\nArm 1:\n\n* Age range: 50 ≤ age \\\u003C 90.\n* Diagnosis of dementia with Lewy bodies (DLB), Parkinson disease dementia (PDD), Parkinson disease with Mild Cognitive Impairment (PD-MCI), Mild Cognitive Impairment with Lewy bodies (MCI-LB).\n* DLB participants must fulfill criteria for clinically probable DLB based on the 2017 4th consensus report of the DLB consortium.\n* PDD participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and must also meet criteria for probable PDD based on the 2007 Movement Disorders Society clinical diagnostic criteria.\n* PD-MCI participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and meet criteria for Mild Cognitive Impairment on cognitive testing at screening.\n* MCI-LB participants with must meet established research criteria.\n* Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.\n* Availability of informant (for participants meeting criteria for dementia).\n* Ability and willingness to comply with the study-related procedures.\n* Fluent in spoken and written English (due to cognitive testing)\n\nExclusion Criteria:\n\nArm 1\n\n* History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.\n* History of deep brain stimulation or any neurosurgical procedure.\n* History of structural brain disease or known significant cerebrovascular disease.\n* History of seizures or epilepsy and\u002For use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.\n* Greater than two alcoholic drinks per day for men and one per day for women.\n* Regular use of benzodiazepines or barbiturates. (If benzodiazepines are taken as needed only, these medications cannot be taken within 5 half-lives of screening visit or between screening visit and EEG.)\n* Severe dementia (based on PI assessment of subject dependence level for instrumental activities of daily living)\n* Any contraindication to brain MRI.\n* Any medical condition that would interfere with ability to complete all study procedures.\n* Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study\n\nInclusion Criteria:\n\nArm 2 (Cholinesterase inhibitor cohort) inclusion criteria:\n\n* Completed Aim 1.\n* Clinical diagnosis of LBD (DLB or PDD) with CF.\n* Not taking a cholinesterase inhibitor and has not taken a cholinesterase inhibitor in the previous 90 days.\n* Ability and willingness to comply with the ChEI Cohort procedures (including galantamine administration), or a caregiver willing and able to ensure compliance.\n\nExclusion Criteria:\n\nArm 2 (Cholinesterase inhibitor cohort) exclusion criteria:\n\n* Severe hepatic impairment.\n* Renal failure.\n* Significant bradycardia (\\\u003C50 bpm) at screening or history of AV block.\n* Any contraindication to galantamine administration based on PI discretion.\n\nInclusion criteria:\n\nArm 3 (Healthy Controls)\n\n* Age range: 50 ≤ age \\\u003C 90.\n* Healthy controls should not have any known neurologic conditions that could interfere with study procedures or results.\n* Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.\n* Availability of informant (for participants meeting criteria for dementia).\n* Ability and willingness to comply with the study-related procedures.\n* Fluent in spoken and written English (due to cognitive testing).\n\nExclusion Criteria:\n\nArm 3 (Healthy Controls)\n\n* No History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.\n* No History of deep brain stimulation or any neurosurgical procedure.\n* No History of structural brain disease or known significant cerebrovascular disease.\n* No History of seizures or epilepsy and\u002For use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.\n* Any medical condition that would interfere with ability to complete all study procedures.\n* Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study","89 Years",{"count":166,"type":21},120,[168],"PHASE4","The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. One of the overarching innovations of study is combining all of these assessments into one integrated research plan",[28,171,172],"Parkinson Disease Dementia","Healthy Controls",[174,175],"Parkinson Disease with Mild Cognitive Impairment","Mild Cognitive Impairment with Lewy Bodies","2026-03-04",{"date":178,"type":40},"2026-03-06",{"date":180,"type":40},"2025-12-08",{"date":182,"type":21},"2029-11",{"name":184,"class":47},"Virginia Commonwealth University",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":117,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":48},"100523662","early-phase-1-pet-imaging-evaluation-of-11csy08-100523662","NCT06098612","PET Imaging Evaluation of [11C]SY08","Inclusion Criteria:\n\n* General Inclusion criteria, all subjects must:\n\n  1. Age 50-80\n  2. Be able to provide written informed consent or assent\n  3. Be able to read, speak and understand English (The investigators do not have the resources necessary to properly study non-English speaking patients in this study, given that translation and validation of the assessment tools would be necessary)\n  4. Be willing and able to participate in one PET\u002FMRI scanning session\n\nAdditional Inclusion criteria for PD patients, subjects must:\n\n1. Have an existing diagnosis of idiopathic PD, using consensus criteria\n2. Stable medications for at least 30 days\n3. Hoehn and Yahr stage I-IV\n4. A study partner who can answer questions pertaining to daily functioning\n\nAdditional Inclusion criteria for MSA patients, subjects must:\n\n1. Have an existing diagnosis of MSA, using consensus criteria\n2. Stable medications for at least 30 days\n3. MSAp or MSAc\n4. A study partner who can answer questions pertaining to daily functioning\n\nAdditional Inclusion criteria for DLB patients, subjects must:\n\n1. Have an existing diagnosis of probable DLB, using consensus criteria\n2. Stable medications for at least 30 days\n3. Clinical Dementia Rating Scale (CDR) \\\u003C 0.5\n4. A study partner who can answer questions pertaining to daily functioning\n\nExclusion Criteria:\n\n* General Exclusion Criteria (All Subjects)\n\n  1. History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled\n  2. Major psychiatric disease (e.g.schizophrenia)\n  3. History of stroke\n  4. Focal brain lesions on MRI scans\n  5. History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness\n  6. Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months\n  7. History of head trauma (as defined as having any insults to the brain that may have resulted from an external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile)\n  8. Impaired elimination (as defined as having problems with urination) unless being managed\n  9. Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed)\n  10. Any present substance abuse including drug\u002Falcohol abuse\n  11. Inability to lie flat on camera bed for up to 90 min\n  12. Pregnancy or breastfeeding\n  13. Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan\n  14. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits (50 milliSieverts)\n\nGeneral MR and PET safety exclusion criteria listed below\n\n1. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing\n2. Electrical implants such as cardiac pacemakers or perfusion pumps\n3. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest\n4. Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)\n5. Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential\n6. Body weight of \\> 300 lbs (weight limit of the MRI table)\n7. Breast feeding mothers\n\nExclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan\n\n1. An abnormal result on the modified Allen's test on both hands\n2. Raynaud syndrome\n3. Bleeding disorder\n4. Use of anticoagulants such as Coumadin, Plavix or Lovenox\n5. An allergy to Lidocaine","80 Years",{"count":20,"type":21},[194],"EARLY_PHASE1","The overall goal of the proposed research is to evaluate the use of \\[11C\\]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls.\n\nThe purpose of this study is to evaluate the use of \\[11C\\]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The specific aims of the current study are:\n\n1. To determine brain uptake, distribution, and kinetics of \\[11C\\]SY08 in healthy individuals.\n2. To determine brain uptake, distribution, and kinetics of \\[11C\\]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA.\n3. To determine human dosimetry of \\[11C\\]SY08 in healthy individuals\n\nAn intravenous bolus injection of \\[11C\\]SY08 will be administered per subject for brain PET imaging.",[197,66,28,172],"Parkinson's Disease","2025-12-18",{"date":200,"type":40},"2025-12-24",{"date":202,"type":40},"2024-05-01",{"date":204,"type":21},"2027-11",{"name":206,"class":47},"Massachusetts General Hospital",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":218,"studyType":58,"phases":4,"briefSummary":219,"conditions":220,"keywords":229,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":248},"100556794","improving-prognostic-confidence-in-neurodegenerative-diseases-causing-dementia-using-peripheral-biomarkers-and-integrative-modeling-100556794","NCT06529744","Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling","CRND TorCA","Inclusion Criteria:\n\n* Possible or probable diagnosis of MCI or early dementia\n* Age 30-95\n* Study partner who has some weekly contact with patient. Some of the neuropsychological assessment require collateral from close contacts to assess cognition and functioning. Since neurodegenerative diseases can be associated with reduced cognition, including reduced awareness of one's own impairments, participants will be assessed for their capacity to consent at all study visits.\n* Must, in the opinion of the site investigator, be able to complete most study procedures.\n\nExclusion Criteria:\n\n* Participants who are not able to complete the majority of assessments in the opinion of the PI are excluded from the study. Exclusion criteria are evaluated at the site investigator's discretion; if the site investigator believes that the participant's symptoms are due to causes other than neurodegeneration, despite the presence of an exclusionary condition, the investigator may overrule the exclusion.","30 Years","95 Years",{"count":217,"type":21},500,"1 Year","To develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).",[221,222,28,223,224,225,226,227,65,228],"Dementia","Alzheimer Disease","Vascular Dementia","Frontotemporal Dementia","Mild Cognitive Impairment","Corticobasal Syndrome","Progressive Supranuclear Palsy","Primary Progressive Aphasia",[230,231,232,233,234,235,236,237,238,239],"alzheimer's disease","dementia","dementia with lewy bodies","vascular dementia","frontotemporal dementia","mild cognitive impairment","corticobasal syndrome","progressive supranuclear palsy","parkinson's disease","primary progressive aphasia","2025-11-17",{"date":242,"type":40},"2025-11-20",{"date":244,"type":40},"2023-11-11",{"date":204,"type":21},{"name":247,"class":47},"University Health Network, Toronto",4,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":266,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":48},"100576488","tdcs-effect-on-psychotic-symptoms-in-dementia-with-lewy-bodies-dlb-and-impacts-on-caregiver-burden-100576488","NCT06785948","tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden","MCL-tDCS","Inclusion Criteria:\n\n* Male or Female, aged over 60,\n* Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria\n* No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion,\n* Mini Mental State Examination (MMSE) \\> 15,\n* Composite score called \"psychotic factor\" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI \\[12\\]) greater than 0,\n* Presence of a family caregiver,\n* Sufficient written and oral expression in French,\n* Written informed consent signed by the patient and his\u002Fher family caregiver\n\nExclusion Criteria:\n\n* History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment,\n* Concomitant major psychiatric illness,\n* Significant physical illness or comorbidities\n* History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,\n* Patient under guardianship or curators","60 Years",{"count":258,"type":21},30,[24],"The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are:\n\n* What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms?\n* What is the impact of tDCS on caregiver burden?\n\nResearchers will compare active tDCS (2mA stimulation, anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital) to Sham tDCS (placebo stimulation, no intensity applied) to see if there is an effect on reducing psychotic-like symptoms and on caregiver burden.\n\nParticipants will:\n\n* Undergo a stimulation phase consisting of 10 tDCS sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).\n* perform assessments at T0 (inclusion), T1 (at the end of the stimulation phase), and T2 (follow-up at 8 weeks post stimulation).",[262,263,264,265,28],"Lewy Body Dementia","Lewy Body Dementia With Behavioral Disturbance","Burden, Caregiver","Lewy Body Disease",[267,268,269,270],"Transcranial Direct-Current Stimulation (t-DCS)","Brain stimulation","Psychotic symptoms","Caregiver burden","2025-09-30",{"date":273,"type":40},"2025-10-01",{"date":275,"type":40},"2025-01-10",{"date":277,"type":21},"2026-11",{"name":279,"class":47},"Association de Recherche Bibliographique pour les Neurosciences",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100484637","phase-4-comparing-antipsychotic-medications-in-lbd-over-time-100484637","NCT05590637","Comparing Antipsychotic Medications in LBD Over Time","A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease","CAMELOT","Inclusion Criteria:\n\n* Patients seen in the neurology clinic at UT Health San Antonio\n* Diagnosed with psychosis due to PD or DLB\n* Requiring initiation of an antipsychotic medication\n* Clinical equipoise between quetiapine and pimavanserin must exist\n* The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin\n\nExclusion Criteria:\n\n* Medical contraindication to either medication\n* Caregiver unavailable to complete NPI-Q\n* Currently taking an antipsychotic medication\n* Prescribing provider unwilling to manage either medication",{"count":289,"type":21},94,[168],"The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and\u002For delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).",[293,28],"Parkinson's Disease Psychosis",[295,296,297,298,299],"quetiapine","pimavanserin","psychosis","hallucinations","delusions","2025-09-08",{"date":302,"type":40},"2025-09-09",{"date":304,"type":40},"2022-04-22",{"date":306,"type":21},"2027-02",{"name":308,"class":47},"The University of Texas Health Science Center at San Antonio",2,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":48},"100464365","non-invasive-neurostimulation-as-a-tool-for-diagnostics-and-management-for-neurodegenerative-diseases-100464365","NCT05326750","Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases","Inclusion Criteria:\n\n* Mild Cognitive Impairment due to Alzheimer's disease\n* Dementia with Lewy Bodies\n* Frontotemporal dementia\n* Idiopathic normal pressure hydrocephalus (iNPH)\n\nExclusion Criteria:\n\n* History of seizures\n* Pregnancy\n* Metal implants in the head (except dental fillings)\n* Electronic implants (i.e. pace-maker, implanted medical pump)\n* Age \\\u003C18 years",{"count":317,"type":21},200,[24],"Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.",[222,224,28],"2025-08-26",{"date":323,"type":40},"2025-09-03",{"date":325,"type":40},"2022-11-21",{"date":327,"type":21},"2032-07",{"name":329,"class":47},"Kuopio University Hospital",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":17,"minAge":336,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":48},"100602392","phase-1-the-effect-of-repetitive-transcranial-magnetic-stimulation-on-cognitive-improvement-in-dementia-with-lewy-bodies-100602392","NCT07122908","The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Improvement in Dementia With Lewy Bodies","Inclusion Criteria:\n\n* Over 65 years of age\n* Meeting the criteria for Probable DLB as proposed in the 2017 DLB diagnostic criteria\n* Scoring between 0.5 and 1 on the Clinical Dementia Rating Scale (CDR)\n\nExclusion Criteria:\n\n* If other causes of cognitive impairment are suspected, such as neurosyphilis, hypothyroidism, hyperthyroidism, metabolic encephalopathy, brain tumor, acute cerebral hemorrhage, acute cerebral infarction, previous territorial or strategic cerebral infarction, Wernicke's encephalopathy, or severe white matter hyperintensity detected in hematological tests, brain MRI, etc.\n* If cooperation for interviews and self-assessment is difficult (e.g., due to hearing impairment, language disorders, severe psychotic conditions)\n* If there is a history of psychiatric disorders: major affective disorder, schizophrenia, or schizo-affective disorder\n* If electroencephalography (EEG) cannot be performed\n* If epileptiform EEG findings are present or if the patient is currently receiving antiepileptic drugs.","65 Years",{"count":338,"type":21},10,[120,91],"This study aimed to investigate the feasibility of repetitive transcranial magnetic stimulation (rTMS) on the occipital lobe in patients with Lewy body dementia.\n\nThis is a proof-of-concept study to evaluate the safety and effect of occipital lobe stimulation in patients with Lewy body dementia. Over a period of two weeks, participants will receive rTMS to the primary visual cortex three times a week during visits. For the remaining 10 weeks, maintenance therapy will be administered with rTMS once a week during visits. Efficacy assessments will be conducted on the day of the final stimulation session and again four weeks later.",[28],"2025-08-07",{"date":344,"type":40},"2025-08-14",{"date":346,"type":40},"2024-04-11",{"date":348,"type":21},"2026-12",{"name":350,"class":47},"Korea University Anam Hospital",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":117,"sex":17,"minAge":55,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":48},"100552005","identification-of-prodromal-neurodegeneration-in-serotonergic-induced-rem-sleep-behavior-disorder-100552005","NCT06467461","Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder","Inclusion Criteria:\n\nSerotonergic REM sleep behavior (5-HT RBD) participants\n\nInclusion Criteria:\n\n* Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram.\n* History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants\n\nInclusion Criteria:\n\n* Age (±3 years) and sex matched to participants with 5-HT RBD\n* On serotonergic medication for at least 6 months without history of dream enactment.\n\nThe following serotonergic medications will be included:\n\nCitalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline\n\nExclusion Criteria:\n\nSerotonergic REM sleep behavior (5-HT RBD) participants\n\nExclusion Criteria:\n\n* Younger than 18\n* Older than 75\n* Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)\n* Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing\n* History of dysarthria, aphasia or other condition which could interfere with speech assessment\n* Reduced capacity to consent\n* MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh\u002Fcoil implants, neurostimulator, insulin pump, IVC filter, etc.).\n* History of allergic response to xylocaine or other local anesthesia\n* Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants\n\nExclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following:\n\n* History of dream enactment that may suggest RBD\n* Increased REM motor tone (REM atonia index \\> 0.10) on PSG suggestive of RBD","75 Years",{"count":359,"type":21},60,[24],"This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus\u002Fsubcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy.\n\nThe investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.",[28,65,64],"2025-07-06",{"date":365,"type":40},"2025-07-08",{"date":367,"type":40},"2024-02-08",{"date":369,"type":21},"2028-09-01",{"name":371,"class":47},"University of Minnesota",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":387,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":48},"100388301","enhancing-outcomes-in-cognitive-impairment-through-use-of-home-sleep-apnea-testing-100388301","NCT04335994","ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing","ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)","ENCHANT","Inclusion Criteria:\n\n* Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE) score of 18-30, or (iii) Toronto Cognitive Assessment (TorCA) score ≤281.\n* A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD); or (ii) Probable AD dementia; or (iii) Possible AD dementia due to limited concomitant cerebrovascular disease; or (iv) Probable Vascular dementia or Vascular Mild Cognitive Impairment, as per the 2011 American Heart Association Scientific Statement; or (v) Patients with a suspected neurodegenerative condition known to be associated with non-OSA sleep disorders (e.g. Parkinson's disease-related dementia and dementia with Lewy Bodies); and\u002For (vi) Mixed disease\n* Have the competency to provide informed consent, or the availability of a substitute decision maker\u002Fcaregiver who can provide consent (if needed).\n* The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed.\n\nExclusion Criteria:\n\n* Prior diagnosis of OSA within the last 2 years\n* Patients already using CPAP or a dental appliance for previously diagnosed OSA.\n* A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink); (b) Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT).\n* Any medical device that would interfere with the placement of the HSAT\n* Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments.",{"count":317,"type":21},[24],"Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI\u002FAD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI\u002FAD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI\u002FAD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.",[384,222,223,225,385,28,386],"Obstructive Sleep Apnea","Parkinsons Disease With Dementia","Mixed Dementia",[384,388,389,390],"Cognitive Impairment","Home Sleep Apnea Test","Screening","2025-05-14",{"date":393,"type":40},"2025-05-18",{"date":395,"type":40},"2019-09-23",{"date":397,"type":21},"2027-06",{"name":399,"class":47},"Sunnybrook Health Sciences Centre",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":117,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":48},"100474610","optical-neuroimaging-and-cognition-100474610","NCT05460143","Optical Neuroimaging and Cognition","Wearable Optical Monitoring of Brain Function in Healthy Adults and People With Dementia","ONAC","Inclusion Criteria:\n\n1. A diagnosis of probable:\n\n   * Lewy Body Dementia\n   * Alzheimer's Disease\n   * Mild Cognitive Impairment (MCI-LB or MCI-AD) OR\n2. Cognitively normal for their education and age, with a MMSE score above 26 AND\n\n   * A good grasp of the English language\n   * An informant (either a carer or family member) who will be available throughout testing (only relevant if in a patient group)\n\nExclusion Criteria:\n\n1. Severe dementia\n\n   * Unable to participate\n   * A MMSE score below 12\n2. A condition which influences metabolism or haemodynamics\n\n   * Such as metabolic or respiratory disorders\n3. A significant mental illness\n\n   * Such as rheumatoid arthritis, systemic lupus erythematosus\n   * Oral steroid use\n4. A significant psychiatric disorder\n5. MCI due to other causes such as traumatic brain injury, vascular dementia, or fronto-temporal dementia\n6. A history of excessive drug or alcohol use\n7. Contraindications to MRI (only for patient groups undertaking the MRI scan: AD\u002FMCI\u002FDLB)\n\n   * Surgical implants e.g. pacemakers\n   * Obesity",{"count":317,"type":21},"Dementia is associated with a variety of neurovascular and neurometabolic abnormalities. Traditional imaging techniques used to investigate such abnormalities, such as Positron Emission Tomography and functional Magnetic Resonance Imaging, are not always well tolerated, have expensive start up and running costs, and are limited with regards to the types of experiments that can be performed as they can be highly sensitive to movement, are noisy, and have physical restrictions.\n\nNear-infrared spectroscopy (NIRS) is a non-invasive neuroimaging technique which uses light in the near-infrared spectrum to detect relative changes in concentration of oxygenated and deoxygenated haemoglobin, and the oxidation state of Cytochrome C Oxidase. As such, NIRS can provide measures of brain oxygenation and metabolism. NIRS is less sensitive to movement, is well tolerated and has few contraindications. It is thus a promising candidate for use in clinics or in peoples' homes for monitoring dementia.\n\nIn the present study, the investigators aim to use both dual-wavelength and broadband NIRS in a range of dementia subtypes, including Alzheimer's Disease and Dementia with Lewy Bodies, and severities, including Mild Cognitive Impairment, to identify how brain oxygenation and metabolism is altered in dementia and across various clinical subgroups. The investigators also aim to determine the relationship between brain oxygenation and metabolism in dementia, and use machine learning approaches to identify optical biomarkers for dementia.",[28,222,225],[221],"2025-04-07",{"date":414,"type":40},"2025-04-10",{"date":416,"type":40},"2023-05-01",{"date":418,"type":21},"2025-09-01",{"name":420,"class":47},"University of Cambridge",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":117,"sex":17,"minAge":55,"maxAge":87,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":309},"100525308","phase-2-18f-mfbg-versus-123i-mibg-and-18f-pe2i-in-pd-vs-msa-and-dlb-vs-ad-100525308","NCT06120049","[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD","Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease","Inclusion Criteria:\n\n1. Healthy Controls:\n\n   * Voluntary written informed consent.\n   * Use of highly effective methods of birth control.\n   * Age between 18 and 85 years.\n   * Good health based on medical history, physical examination, clinical laboratory tests, and urinalysis.\n   * No history or evidence of major neurological, internal, or psychiatric disorders.\n   * Normal structural MRI scan for subjects \\\u003C 60 years or minor lesions for subjects \\>= 60 years.\n2. Parkinson's Disease:\n\n   * Age 45-85 years.\n   * Clinically established PD based on Movements Disorder Society diagnostic criteria.\n   * Disease duration since onset of motor symptoms: 5 years or longer for one group and less than 5 years for another.\n   * Previous abnormal \\[18F\\]-FE-PE2I PET or \\[123I\\]-FP-CIT SPECT scan.\n   * Ability to understand the patient information brochure and provide written informed consent.\n3. Multiple System Atrophy - Parkinsonian Variant:\n\n   * Age 45-85 years.\n   * Clinically established or clinically probable MSA-P based on MDS diagnostic criteria.\n   * Previous abnormal \\[18F\\]-FE-PE2I PET or \\[123I\\]-FP-CIT SPECT scan.\n   * Ability to understand the patient information brochure and provide written informed consent.\n4. Dementia Due to Alzheimer's Disease:\n\n   * Age 50-85 years.\n   * Diagnosis of probable AD with evidence of the AD pathophysiological process.\n   * Ability to understand the patient information brochure and provide written informed consent.\n5. Dementia with Lewy Bodies:\n\n   * Age 50-85 years.\n   * Diagnosis of probable DLB.\n   * Previous abnormal \\[18F\\]-FE-PE2I PET or \\[123I\\]-FP-CIT SPECT scan.\n   * Ability to understand the patient information brochure and provide written informed consent.\n\nExclusion Criteria:\n\n1. Healthy controls:\n\n   * Major diseases that may interfere with the investigations.\n   * Evidence of cognitive impairment.\n   * History or evidence of psychiatric disease.\n   * Use of illicit drugs or history of drug or alcohol abuse.\n   * Chronic medication interfering with cardiac neuronal norepinephrine transporter (NET) or \\[18F\\]-FE-PE2I imaging.\n   * Exposure to ionizing radiation \\> 1 mSv in other research studies within the last 12 months.\n   * Contraindication for MRI scanning.\n   * Claustrophobia or inability to tolerate confinement during PET-MRI scanning.\n   * Unwillingness to avoid strenuous physical activity.\n   * Lack of understanding of the study procedures.\n   * Pregnancy or breastfeeding.\n   * Lack of agreement to communicate incidental findings to the general practitioner.\n   * Abnormal Allen test or lidocaine hypersensitivity\u002Fallergy for subjects willing to undergo arterial sampling.\n2. Parkinson's Disease:\n\n   * Neuropsychiatric diseases other than PD.\n   * Major internal medical comorbidity, especially diabetes or heart disease.\n   * White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities.\n   * History of alcohol or drug abuse.\n   * Previous participation in research studies involving ionizing radiation.\n   * Contraindications for MR.\n   * Claustrophobia or inability to tolerate confinement during PET scanning.\n   * Unwillingness to avoid strenuous physical activity.\n   * Lack of understanding of the study procedures.\n   * Pregnancy or breastfeeding.\n   * Lack of agreement to communicate incidental findings to the general practitioner.\n   * Anticoagulant therapy.\n3. Multiple System Atrophy - Parkinsonian Variant:\n\n   * Same as for Parkinson's disease.\n4. Dementia Due to Alzheimer's Disease:\n\n   * Same as for Parkinson's disease.\n5. Dementia with Lewy Bodies:\n\n   * Same as for Parkinson's disease.",{"count":429,"type":21},113,[91,431],"PHASE3","Study goal:\n\nThe goal of this prospective head to head comparison is to evaluate the effectiveness of \\[18F\\]-MFBG PET in assessing cardiac innervation, comparing it with \\[123I\\]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD).\n\nMain questions:\n\n* Feasibility: How well can \\[18F\\]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients? How well can it differentiate between these groups based on the detected changes?\n* Non-inferiority: Is \\[18F\\]-MFBG PET as accurate as \\[123I\\]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD?\n\nParticipant requirements:\n\nFor the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, \\[18F\\]-PE2I PET, \\[123I\\]-MIBG SPECT, and \\[18F\\]-MFBG PET scans.\n\nAdditionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo \\[18F\\]-MFBG PET scans.",[65,28,434,222],"MSA - Multiple System Atrophy",[65,436,434,222,437,438,439,440,126,441,442,443,444,445,446,447,448,221,449,450,451,452,453],"Dementia with Lewy Bodies","[18F]-MFBG","[18F]-PE2I","[123I]-MIBG","Positron emission tomography","Single photon emission tomography","SPECT","Autonomic dysfunction","Cardiac innervation","Brain DAT","Dosimetry","Kinetic modelling","Differential diagnosis","Parkinsonism","Nuclear imaging","Neurology","Movement disorders","Prospective","2025-02-03",{"date":456,"type":40},"2025-02-06",{"date":458,"type":40},"2024-01-19",{"date":460,"type":21},"2026-07",{"name":462,"class":47},"prof. dr. Koen Van Laere",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":473,"conditions":474,"keywords":476,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":48},"100427288","cerebro-spinal-fluid-collection-csf-100427288","NCT04844060","Cerebro Spinal Fluid Collection (CSF)","Analysis of Clinical Data and Diagnosis in Any Person Requiring an Assay of Alzheimer Biomarkers in Cerebrospinal Fluid","Analzheimer","Inclusion Criteria:\n\n* Patients with lumbar puncture (LP)\n* Patients with accurate clinical diagnosis\n\nExclusion Criteria:\n\n* Patients who do not have a lumbar puncture\n* Patients for whom no accurate diagnostic information is available",{"count":472,"type":21},10000,"Cognitive neurodegenerative diseases are a major public health issue. At present, the diagnosis of certainty is still based on anatomopathological analyses. Even if the diagnostic tools available to clinicians have made it possible to improve probabilistic diagnosis during the patient's lifetime, there are still too many diagnostic errors and sub-diagnostic in this field. The arrival of biomarkers has made it possible to reduce these diagnostic errors, which were of the order of 25 to 30%. This high error rate is due to different parameters. These diseases are numerous and often present common symptoms due to the fact that common brain structures are affected. These diseases evolve progressively over several years and their early diagnosis, when the symptoms are discrete, makes them even more difficult to diagnose at this stage. In addition, co-morbidities are common in the elderly, further complicating the diagnosis of these diseases.\n\nAt present, the only cerebrospinal fluid (CSF) biomarkers that are routinely used for the biological diagnosis of neurodegenerative cognitive pathologies are those specific to Alzheimer's disease: Aβ42, Aβ40, Tau-total and Phospho-Tau. These biomarkers represent an almost indispensable tool in the diagnosis of dementia.\n\nIt is therefore important to determine whether Alzheimer's biomarkers can be disrupted in other neurodegenerative cognitive pathologies, but also to find biomarkers specific to these different pathologies by facilitating the implementation of clinical studies which will thus make it possible to improve their diagnosis.",[222,28,224,475,66],"Parkinson's Disease Dementia",[477,478],"CSF library","Database of patients with cognitive disorders","2023-04-26",{"date":481,"type":40},"2023-04-27",{"date":483,"type":40},"2010-02",{"date":155,"type":21},{"name":46,"class":47},{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":117,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":48},"100441071","pumch-dementia-longitudinal-cohort-study-100441071","NCT05023564","PUMCH Dementia Longitudinal Cohort Study","Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study","Inclusion Criteria:\n\n* Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia\n* Fixed care giver and can follow up regularly\n\nExclusion Criteria:\n\n* Not demented, including MCI\n* Systemic severe diseases and severe vision or hearing problem effecting follow up and neuropsychological evaluation\n* Without fixed care giver\n* Reject informed consent\n* Expected life shorter than 2 years",{"count":494,"type":21},20000,"The PUMCH Dementia Cohort is a hospital-based, observational study of Chinese elderly with cognitive impairment.",[221,497,28,498,499,500,501],"Dementia, Vascular","Dementia, Mixed","Dementia Alzheimers","Dementia Frontal","Dementia, Mild","2022-09-10",{"date":504,"type":40},"2022-09-13",{"date":506,"type":40},"2020-12-01",{"date":508,"type":21},"2040-12-31",{"name":510,"class":47},"Peking Union Medical College Hospital",{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":17,"minAge":518,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":521,"conditions":522,"keywords":527,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":537,"locationsCount":48},"100224095","modifiable-variables-in-parkinsonism-mvp-100224095","NCT02194816","Modifiable Variables in Parkinsonism (MVP)","Modifiable Variables in Parkinsonism (MVP) [Formerly CAM Care in PD]","Inclusion Criteria:\n\n* Parkinson's disease (PD)\n* Parkinsonism\n* Parkinson-plus syndromes (e.g. Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Corticobasal degeneration (CBGD), Dementia with Lewy bodies)\n* Must have online access, an email address, basic computer literacy\n* Must be willing to complete online surveys every 6 months for 5 years\n\nExclusion Criteria:\n\n* Inability to read\u002Fwrite English\n* Inability or unwillingness to complete surveys every six (6) months (\\~90 min)","19 Years",{"count":520,"type":21},2000,"We are trying to identify factors associated with improved quality of life and fewer PD symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals who report excellent quality of life, few PD symptoms, and reduced rates of progression. After agreeing to participate, we will ask participants to fill our questionnaires about their experience with PD, their health in general, along with their food intake every six months for five years.",[197,449,434,227,523,524,28,525,526],"Shy-Drager Syndrome","Corticobasal Degeneration","Pick Disease","Olivopontocerebellar Atrophies",[197,528,529,530],"PD","Complementary and Alternative","CAM","2022-03-10",{"date":533,"type":40},"2022-03-25",{"date":535,"type":4},"2012-09",{"date":155,"type":21},{"name":538,"class":47},"Bastyr University"]