[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dementia-with-lewy-bodies-dlb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dementia-with-lewy-bodies-dlb":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,74,107,157,182],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100611455","digital-health-technologies-for-progressive-supranuclear-palsy-and-dementia-with-lewy-bodies-100611455",false,"NCT07240805","Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies","Digital Health Technologies For Monitoring Disease Symptoms in Progressive Supranuclear Palsy and Dementia With Lewy Bodies","Inclusion Criteria:\n\n* Male and female participants aged 40-89 meeting clinical diagnostic criteria for probable PSP, probable MCI-LB or probable DLB.\n* Able to be present for all study procedures, complete questionnaires and assist during home data collection.\n* Eligible participants must be fluent in reading and speaking English and must be capable of providing informed consent based on the principal investigator's judgment.\n* Must have a caregiver or study partner who is willing and able to assist with all study-related procedures.\n* Ambulatory (able to take 10 steps with minimal support such as use of a cane)\n\nExclusion Criteria:\n\n* Any neurological, medical, or psychiatric condition that would preclude or confound participation in study activities based on the investigator's judgment.\n* History of frequent falls defined as more than 5 falls per month, will not be eligible to participate in the study.","ALL","40 Years","89 Years",{"count":20,"type":21},60,"ESTIMATED","OBSERVATIONAL","Progressive supranuclear palsy (PSP), mild cognitive impairment with Lewy bodies (MCI-LB), and Dementia with Lewy Bodies (DLB) are severe neurodegenerative diseases that cause significant motor impairment impacting daily function. Researchers at BioSensics, Johns Hopkins School of Medicine, Massachusetts General Hospital and their collaborators aim to conduct an analytical and clinical validation of wearable-based digital health technologies for monitoring upper and lower limb function in PSP, MCI-LB and DLB that could enable frequent, at-home monitoring and be incorporated into future clinical trials.",[25,26,27,28,29],"Progressive Supranuclear Palsy(PSP)","Dementia With Lewy Bodies (DLB)","PSP","Lewy Body Dementia (LBD)","Lewy Body Disease","NOT_YET_RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":21},"2026-06-15",{"date":38,"type":21},"2029-01-01",{"name":40,"class":41},"BioSensics","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100639031","dementia-with-lewy-bodies-clinical-symptoms-biomarkers-and-progression-100639031","NCT07629349","Dementia With Lewy Bodies: Clinical Symptoms, Biomarkers and Progression","Find-DLB","Inclusion Criteria:\n\n* At least one core clinical feature of dementia with Lewy bodies such as visual hallucinations, parkinsonism, cognitive fluctuations, or probable REM sleep behaviour disorder.\n\nExclusion Criteria:\n\n* Causes of cognitive impairment other than those related to dementia or MCI. Current or pass drug use.",true,{"count":52,"type":21},600,"The goal of this observational study is to improve the detection of dementia with Lewy bodies (DLB) and its prodromal phases, as well as advancing our current understanding of biological mechanisms and therapeutic options. The data is acquired at cognitive clinics in Stockholm (Sweden) and combined with national and international data to increase statistical power, representativeness and replication of results. Participants undergo collection of clinical assessments, neuroimaging and fluid biomarkers.",[26,55,56,57],"Mild Cognitive Impairment (MCI)","Cognitively Unimpaired","Other Dementias",[59,60,61],"case-control","retrospective","longitudinal","RECRUITING","2026-06-04",{"date":65,"type":34},"2026-06-05",{"date":67,"type":34},"2020-01-01",{"date":69,"type":21},"2031-03-01",{"name":71,"class":72},"Karolinska Institutet","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":42},"100640300","early-molecular-biomarkers-for-differentiating-parkinsonian-syndromes-100640300","NCT07604883","Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes","Identification of Molecular Biomarkers, Including microRNAs and Metabolites, Enabling Early Differentiation of Parkinson's Disease and Atypical Parkinsonian Syndromes in a Prospective Observational Study.","BIOMARK-PS","Inclusion Criteria:\n\nPatients with suspected neurodegenerative parkinsonism in the course of PD or APS, defined according to the 2015 MDS criteria as bradykinesia accompanied by at least one additional symptom: rigidity and\u002For resting tremor.\n\nAge between 40 and 80 years. Written informed consent for participation in the study. Duration of parkinsonian symptoms shorter than 3 years. Abnormal dopamine transporter single-photon emission computed tomography (DaTscan) result confirming presynaptic dopaminergic neuronal degeneration.\n\nExclusion Criteria Lack of consent to participate in the study. Secondary or drug-induced parkinsonism. Other central nervous system (CNS) disorders (e.g., neoplastic or vascular processes) that could account for the symptoms.\n\nActive malignancy, infection, or autoimmune inflammatory disease. Severe systemic diseases, including advanced heart failure (New York Heart Association \\[NYHA\\] class III-IV), poorly controlled diabetes mellitus, renal failure with glomerular filtration rate (GFR) ≤ 60 mL\u002Fmin\u002F1.73 m², or hepatic failure.\n\nPresence of a known monogenic mutation causing parkinsonism according to the Online Mendelian Inheritance in Man (OMIM) classification.\n\nAntibiotic therapy or use of probiotics within 3 months prior to the study visit.\n\nPregnancy or breastfeeding.","80 Years",{"count":84,"type":21},200,"This prospective observational study aims to identify and preliminarily validate molecular biomarkers, including microRNAs and metabolites, for the early differentiation of Parkinson's disease (PD) from atypical parkinsonian syndromes (APS). The study will enroll up to 100 patients with PD, 50 patients with suspected APS, and 50 healthy controls.\n\nParticipants will undergo clinical assessments and provide blood, urine, and stool samples at baseline and after 12-18 months of follow-up. Molecular analyses, including microRNA profiling, metabolomics, RNA sequencing (RNA-seq), and microbiome analysis, will be performed to identify disease-specific diagnostic signatures.\n\nThe primary objective is to detect differences in molecular profiles among patients with PD, patients with APS, and healthy controls. Secondary objectives include evaluating the diagnostic accuracy of biomarker panels and assessing longitudinal changes in these biomarkers over time.\n\nAlthough participants will not receive direct therapeutic benefits, the study may contribute to the development of non-invasive tools for the early diagnosis and improved differentiation of parkinsonian disorders.",[87,88,89,90,26],"PARKINSON DISEASE (Disorder)","Atypical Parkinsonism","Multiple System Atrophy","Progressive Supranuclear Palsy (PSP)",[92,93,94,95,96,97],"parkinson disease","atypical parkinsonism","progressive supranuclear palsy","multiple system atrophy","dementia with lewy bodies","biomarker","2026-05-25",{"date":100,"type":34},"2026-05-28",{"date":63,"type":21},{"date":103,"type":21},"2029-06-04",{"name":105,"class":106},"International Institute of Molecular and Cell Biology in Warsaw","OTHER_GOV",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":50,"sex":16,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":132,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":73},"100632087","ultra-high-resolution-pet-in-aging-neurodegeneration-and-psychotic-disorders-100632087","NCT07509125","Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders","Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders","Inclusion Criteria:\n\n* WP1: Healthy controls\n* Age between 18 and 90 years old (15 aged 18-50 years and 25 aged 50 90 years);\n* Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests;\n* No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment;\n* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;\n* In subjects \\\u003C 60 years of age, a normal structural MRI scan as assessed by expert radiologist.\n* In subjects \\>= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score \\\u003C= 2 (of 3) on the Age-Related White Matter changes scale are acceptable;\n* When older than 50 years of age, the volunteer is willing to undergo a p- tau217 blood sample.\n* WP2: Dementia\n* Patient has a clinical diagnosis of biomarker-proven prodromal AD\n* WP3: ALS spectrum\n* Subject must meet El Escorial Criteria (30) and Awaji-Shima criteria (31) for at least possible ALS;\n* WP4: Movement disorders\n* (all): Patient (or legal representative, when applicable) is able to understand the patient information form and give written informed consent.\n* Parkinson´s disease (PD):\n* Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria (32);\n* Patient has an abnormal 18F-PE2I PET;\n* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline.\n* Multiple system atrophy (MSA)\n* Patient has clinically established or clinically probable MSA-P based on the\n* Movement Disorder Society (MDS) diagnostic criteria (33);\n* Patient has an abnormal 18F-PE2I PET.\n* Progressive supranuclear palsy (PSP)\n* Patient has an abnormal 18F-PE2I PET;\n* Patient has clinically established probable PSP according to the latest MDS criteria\n* Dementia with Lewy bodies (DLB)\n* Patient has probable DLB by consensus criteria (cognitive impairment MoCA \\\u003C 26 + visual hallucinations and\u002For fluctuating alertness);\n* Patient has an abnormal 18F-PE2I PET.\n* Idiopathic REM sleep behavior disorder (iRBD)\n* Patient has Polysomnography-confirmed iRBD;\n* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;\n* No clinical evidence of parkinsonism at baseline.\n* WP5: Psychosis\n* DSM 5 criteria for a non-affective schizophrenia spectrum psychotic disorder;\n* Age between 18 and 55 years old for adult-onset psychosis, onset of psychosis (and age) above 60 years old for very late onset psychosis.\n\nExclusion Criteria:\n\n* Subject has a history of any major (other) internal, psychiatric or neurological disease that may interfere with the investigations (especially liver and kidney disease, uncontrolled diabetes, cancer, severe depression, stroke, severe TBI);\n* Subject is currently a user (including recreational use) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse;\n* Subject chronically uses medication that has central nervous system effects (e.g. strong painkillers such as opioids, neuroleptics,..; ) (other than prescribed for the illness in case of patients);\n* Subject has had exposure to ionizing radiation (\\> 1 mSv) in other research studies within the last 12 months;\n* Subject has a contra-indication for MRI scanning;\n* Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for (at least) 60 minutes inside the scanner;\n* (For subjects with arterial sampling): The subject is hypersensitive to lidocaine (used for local anaesthesia during the placement of the arterial catheter), has an abnormal Allen test (a test to check blood flow in the arteries of the forearm) or is on anti-coagulant therapy;\n* Subject (or his\u002Fher legal representative) does not understand the study procedures;\n* Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;\n* Subject is potentially pregnant (hCG test can be done if doubt exists).","18 Years","90 Years",{"count":117,"type":21},300,"INTERVENTIONAL",[120],"NA","The goal of this study is to use ultra-high-resolution (UHR) PET imaging to better understand how the brain and spinal cord change in healthy aging and in neurological and psychiatric disorders such as Alzheimer's disease (AD), Parkinson's disease and related movement disorders, amyotrophic lateral sclerosis (ALS), and psychotic disorders. Researchers will use the NeuroExplorer PET\u002FCT system, a new scanner that can show very small structures in the brain and spinal cord in much more detail than regular PET.\n\nThe main questions this study aims to answer are:\n\n* How do small but important brain regions (like the locus coeruleus, substantia nigra, and thalamic nuclei) change in healthy aging?\n* What early brain changes occur in neurodegenerative and psychotic disorders, and can they help improve early diagnosis?\n\nParticipants will:\n\n* Undergo PET and MRI brain scans using different tracers that measure brain metabolism (18F-FDG), synaptic density (¹⁸F-SynVesT-1), dopamine transporters (¹⁸F-PE2I), and tau protein buildup (¹⁸F-MK6240).\n* Complete cognitive and clinical assessments related to memory, mood, and motor or psychiatric symptoms, depending on their group.\n\nThis study will include healthy volunteers and patients with mild cognitive impairment due to Alzheimer´s disease, ALS, Parkinson's disease and related disorders, or psychotic disorders.\n\nThe results will help create detailed brain imaging maps for healthy aging and identify early biomarkers for different diseases to support better diagnosis and treatment in the future.",[123,124,125,126,127,128,26,129,130,131],"Alzheimer Dementia (AD)","ALS - Amyotrophic Lateral Sclerosis","Parkinson s Disease","REM Sleep Behavior Disorder (iRBD)","PSP - Progressive Supranuclear Palsy","MSA - Multiple System Atrophy","ALS With Frontotemporal Dementia (ALS\u002FFTD)","Adult Onset Psychotic Disorder","Very Late Onset Psychotic Disorder",[133,134,135,136,137,138,139,89,140,141,142,143,144,145,146,147],"PET\u002FCT scan","Alzheimer´s disease","Dementia","Amyotrophic Lateral Sclerosis","Parkinson´s disease","REM sleep behavior disorders","Progressive supranuclear palsy","Dementia with Lewy Bodies","Psychotic disorders","Schizophrenia","ALS with frontotemporal dementia","UHR PET","Locus coeruleus","Papez circuit","Thalamic subnuclei","2026-03-27",{"date":150,"type":34},"2026-04-03",{"date":152,"type":34},"2026-02-13",{"date":154,"type":21},"2029-09",{"name":156,"class":72},"Universitaire Ziekenhuizen KU Leuven",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":50,"sex":16,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":118,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":73},"100584619","early-phase-1-18faci-15916-pet-in--synucleinopathies-100584619","NCT06891703","[18F]ACI-15916 PET in α-synucleinopathies","Phase 1 Study to Evaluate [18F]ACI-15916 as a Potential PET Radioligand for Imaging α-synuclein Deposits in the Brain of Patients With Suspected α-synuclein Pathology Compared With Healthy Volunteers","Inclusion Criteria for all Participants:\n\n1. Subject is able to provide written informed consent, which must be obtained before any assessment is performed.\n2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.\n3. Body mass index is \\> 18 and \\\u003C 31 kg\u002Fm2 and Bodyweight ≥ 50 kg and ≤ 100 kg.\n4. Female participants must not be of childbearing potential or agree to use highly effective methods of contraception.\n5. For subjects receiving arterial cannulation, an adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test).\n\n   Additional Inclusion Criteria for Healthy Volunteers:\n6. Males and females aged ≥ 20 at the time of signing the informed consent.\n7. Normal MRI and DAT PET or SPECT (except for Part 4 participants), as judged by the investigator.\n8. The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, ECG, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests.\n9. No family history of α-synucleinopathy, including PD, or other early-onset neurological disease associated with dementia.\n10. No personal history of clinically significant neurologic and\u002For psychiatric disorders.\n11. Have a Montreal Cognitive Assessment (MoCA) score ≥ 26\n12. No cognitive impairment as judged by the PI or delegated physician.\n\n    Additional Inclusion Criteria for Participants with α-synucleinopathies:\n13. Males and females aged ≥ 40 at the time of signing the informed consent.\n14. Subjects diagnosed with any of the following:\n\n    * Idiopathic PD based on MDS criteria\n    * PD with genetic risk factor (except some mutations as mentioned in exclusion criteria)\n    * Dementia with Lewy bodies (DLB)\n    * Diagnosis of possible or probable Multiple System Atrophy (MSA)\n15. Evidence of dopamine transporter deficit on DAT PET or SPECT imaging performed either as part of Screening or previously acquired (if not older than 6 months) and of good quality as judged by the investigator.\n16. Medications taken for symptomatic treatment of α-synucleinopathy must be maintained on a stable dosage regimen for at least 30 days before the Screening Visit.\n\nExclusion Criteria for all Participants:\n\n1. Female subjects pregnant, lactating or breastfeeding.\n2. Presence of psychiatric symptoms that may interfere with the objectives of the study, as judged by the investigator.\n3. Clinically significant concomitant disease or condition within 6 months prior to screening, that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant, or compromise the scientific quality of the study.\n4. History of brain surgery or any neurosurgical procedures. Subject has received treatment with a drug, antibody or vaccine targeting α-synuclein.\n5. Known or suspected drug, alcohol or other abuse, or positive urine drug screen which may interfere with the study objective, as judged by the investigator.\n6. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity as judged by the investigator.\n7. Subject is involved in the planning and\u002For conduct of the study (i.e. part of the study team)\n8. History of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator.\n9. History of and\u002For screening brain MRI scan (except for Part 4 subjects) indicative of, clinically significant abnormality including but not limited to prior haemorrhage or infarct or \\>3 lacunar infarcts, except changes consistent with α-synucleinopathies for PD, MSA, DLB patients.\n10. Subjects being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower within 2 weeks of the planned arterial cannula placement (if performed) for either the baseline or retest imaging.\n11. Screening supine blood pressure \\> 150 mm Hg (systolic) or \\> 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is \\> 150 mm Hg (systolic) or \\> 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.\n12. Electrocardiographic (ECG) abnormalities of clinical significance as judged by the investigator. Screening supine 12-lead ECG demonstrating QTc \\> 450 msec at Screening.\n13. Any contraindications to obtaining a brain MRI (except for Part 4 subjects), DaT-SPECT (except for Part 4 subjects) or PET (e.g., claustrophobia unresponsive to reassurance or low dose of an anxiolytic agent, metal implants not compatible with MRI or known hypersensitivity to the active substance or to any of the excipients) and ability to tolerate lying in the scanner for up to \\~180 minutes.\n14. Previous exposure to radiation for medical, scientific or other reasons which could have a high negative impact on the research subject, as judged by the investigator.\n15. Treatment with any other investigational therapy within 5 drug elimination half-lives or 30 days (whichever is longer) prior to inclusion in the study.\n\n    Additional Exclusion Criteria for Healthy Volunteers:\n16. Current use of CNS active drugs, including antidepressant or neuroleptic medications is not permitted, anti-inflammatory drugs or sleep medications may be allowed at the discretion of the investigator.\n17. History of neurological disease\u002Fcondition that may interfere with the objectives of the study, as judged by the investigator.\n\n    Additional Exclusion Criteria for Participants with α-synucleinopathy:\n18. Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including but not limited to, progressive supranuclear palsy, drug-induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia or corticobasal syndrome (CBS).\n19. Known carriers of certain familial PD gene mutations (PRKN, PINK1, DJ1, LRRK2), based on previous source documentation.","20 Years",{"count":166,"type":21},46,[168],"EARLY_PHASE1","The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein α-synuclein \\[involved in some diseases such as Parkinson's disease, Lewy body dementia and Multiple System Atrophy (MSA), collectively named α-synucleinopathies\\] using a new positron emission tomography (PET) tracer called \\[18F\\]ACI-15916. Both healthy people and people with (suspected) α-synuclein pathology will participate to this trial.\n\nThe main questions it aims to answer are:\n\n* whether \\[18F\\]ACI-15916 is safe and well tolerated when injected into participants\n* whether \\[18F\\]ACI-15916 reliably detects α-synuclein in the brain using PET technique.\n* whether there are differences in the amount of this protein between people with diseases related to α-synuclein accumulation in the brain and people without these diseases.\n\nParticipants will:\n\n* Visit the clinic to consent to their participation and to ensure they are eligible \\[physical and neurological examinations, questionnaires, blood and urine tests, ECG and in some cases a MRI and a PET scan with a licensed tracer (\\[18F\\]FE-PE2I) to confirm or not the disease\\].\n* Visit the clinic to receive the tracer \\[18F\\]ACI-15916 intravenously and be scanned in a PET scanner, during which blood will be collected (and optionally spinal fluid).\n* Receive a phone call from the clinic 1 week after the PET scan to report any symptoms and side-effects that they may be having.\n\nSome of the participants may be asked to come again to the clinic for a second PET scan with \\[18F\\]ACI-15916, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.\n\nSome of the participants will participate in a specific part of the study to evaluate the distribution of the PET ligand in the whole body, with a similar visit schedule.",[171,172,26],"Parkinson's Disease (PD)","Multiple System Atrophy (MSA)","2025-11-18",{"date":175,"type":34},"2025-11-19",{"date":177,"type":34},"2025-03-20",{"date":179,"type":21},"2026-03",{"name":181,"class":41},"AC Immune SA",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":114,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":118,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":4},"100605763","contribution-of-pathological-alpha-synuclein-as-a-diagnostic-biomarker-for-dementia-with-lewy-bodies-100605763","NCT07166744","Contribution of Pathological Alpha-synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies","Contribution of Pathological Alpha-Synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies","QuIC-Lewy","Inclusion Criteria:\n\n* \\- Patient, male or female, age equal or over 50 with signs suggestive of one of the following conditions: Lewy body disease (LBD) according to the criteria of McKeith et al. 2017 and 2020, + positive DAT-scan at inclusion applying, if necessary, usual biomarkers such as polysomnography and MIBG scintigraphy. Patients with non-significant (0 or 1 out of 3) Alzheimer's disease LCS biomarkers (P-Tau, Tau, and Abeta42\u002F40) or Alzheimer's disease (AD) biomarkers (0 or 1 out of 3) will be considered as true MCL following lumbar puncture as part of the protocol.\n* Alzheimer's disease (AD) according to the criteria of Dubois et al. 2014, or\n* MCL + AD disease according to the criteria of McKeith et al. 2017 and 2020 + a positive DAT-scan at inclusion and Dubois et al. 2014, or\n* Fronto-temporal diseases (FTD) in the broad sense: taupathy or tardopathy: fronto-temporal lobar dementia (FTLD) according to the criteria of Rascovsky et al., 2011, or cortico-basal degeneration (CBD) according to the criteria of Amstrong et al., 2013, or supranuclear palsy according to the criteria of Höglinger et al., 2017, or age-related predominantly limbic TDP-43 encephalopathy (LATE).\n* Psychiatric disorders such as depression, bipolarity, schizophrenia according to DSM 5 criteria.\n* Patient accompanied by a caregiver or a person likely to provide information about him\u002Fher (interview, telephone contact) in case the investigator deems the patient unable to provide this information alone.\n* Patient able to understand the aims and risks of the research and to give dated, signed informed consent (or consent given by the trusted support person\u002Fguardian, or in the presence of the curator if the patient is under guardianship or curatorship).\n* Patient affiliated to a social health insurance protection.\n* Patient presenting at syndromic level :\n\neither mild cognitive impairment (according to Petersen criteria) or mild, moderate or severe dementia (MMSE 30 to 5 included)\n\nExclusion Criteria:\n\n* Patient with other neurological disease including, but not limited to, the following conditions: cerebral tumor, cerebrovascular accident with cognitive impairment, multisystem atrophy, etc, as judged by the investigator.\n* Patient with a contraindication to lumbar puncture.\n* Patient with a contraindication to cerebral MRI (patients included in Strasbourg only).\n* Any reason making it impossible to follow up the patient during the study period (planned move, etc.).\n* Patient under Legal safeguard (\"sauvegarde de justice\")- Impossibility of giving the patient informed information (patient in emergency or life-threatening situation).\n\nPatients under guardianship or curatorship may be included in the study; in fact, in severe to moderately severe patients (MMS\\\u003C15), such a measure is often in place.\n\n\\-",{"count":191,"type":21},286,[120],"Alzheimer's disease and dementia with Lewy bodies (DLB) are the two main age-related neurodegenerative cognitive disorders. Differential diagnosis between these conditions is challenging, both at the prodromal and dementia stages. The lack of a precise diagnosis can be particularly harmful for patients with DLB, as up to 80% of them show severe adverse reactions to antipsychotic medications, including falls, confusion, and even death. The diagnosis of Alzheimer's disease has improved with cerebrospinal fluid (CSF) biomarkers such as Tau, phosphorylated Tau (P-Tau), and the Aβ42\u002FAβ40 ratio (Lehmann et al., 2018). However, differentiating Alzheimer's disease from DLB remains difficult: 1 to 3 Alzheimer's biomarkers are frequently positive in the CSF of patients with DLB: in 49% of cases at the prodromal stage and up to 72% at the dementia stage. Moreover, total α-synuclein measurement in CSF has not proven to be diagnostically reliable. The DAT-scan, sometimes used as a supportive tool, is an expensive technique and lacks sensitivity, with detection rates of only 78% in dementia-stage DLB and 54% in prodromal DLB.\n\nGiven these limitations, identifying specific biomarkers for DLB, particularly pathological α-synuclein, is a critical objective. α-synuclein is the main protein component of Lewy bodies, whose abnormal β-sheet conformation promotes aggregation and prion-like propagation. Conventional measurements of total α-synuclein in CSF have failed to achieve sufficient diagnostic specificity. In contrast, detecting aggregated or pathological forms of α-synuclein in CSF appears to be a promising approach for improving the diagnosis of synucleinopathies. New techniques based on α-synuclein aggregation amplification have shown encouraging results in retrospective studies including neuropathologically confirmed cases (Bargar et al., 2021; Rossi et al., 2020). However, prospective evaluation of these methods in real-world clinical settings is still lacking. We hypothesize that a specific assay targeting pathological α-synuclein in CSF could reliably distinguish patients with DLB from those with Alzheimer's disease.",[26,195],"Alzheimer's Disease (AD)","2025-09-08",{"date":198,"type":34},"2025-09-10",{"date":200,"type":21},"2026-01-01",{"date":202,"type":21},"2032-01-01",{"name":204,"class":72},"University Hospital, Strasbourg, France"]