[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimers-disease-ad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimers-disease-ad":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,69,92,124,160,195,219,249,271,306,335,365,388,417,447],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645292","the-bridge-towards-implementation-of-blood-based-biomarkers-to-enable-early-and-accurate-diagnosis-of-alzheimers-disease-100645292",false,"NCT07680335","The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease","The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)","BRIDGE-AD2","Inclusion Criteria:\n\n* Patient presents in memory clinic with cognitive complaints.\n* The physician is concerned about underlying AD as etiology of the complaints.\n* Adequate fluency in Dutch to understand informed consent procedure.\n\nExclusion Criteria:\n\n* Age under 55.\n* Previous biomarker-confirmed diagnosis of AD.\n* Alcohol or drug abuse to such an extent that treatment would be advisable.\n* Patient is incapacitated, and is not able to judge consequences of participation.","ALL","55 Years",{"count":20,"type":21},550,"ESTIMATED","INTERVENTIONAL",[24],"NA","Cognitive disorders have a broad differential diagnosis, and a precise, timely diagnosis is essential for personalized treatment and care. Currently, dementia diagnoses are often not further specified according to the underlying pathology and are frequently delayed by several years. However, with the upcoming disease-modifying treatments (DMTs) for AD, an accurate, pathology-driven (i.e., etiological) diagnosis will become necessary.\n\nBlood-based biomarkers (BBMs) are promising tools for detecting Alzheimer's disease (AD), with current research showing high concordance with cerebrospinal fluid (CSF) biomarkers and amyloid PET imaging. However, it remains unclear how physicians would value the availability of BBMs for AD in routine clinical practice. The investigators hypothesize that BBMs will benefit both patients and physicians in the diagnostic process within a memory clinic setting.\n\nThis study aims to investigate clinical impact and diagnostic utility of blood-based biomarkers for AD in the diagnostic process of a memory clinic. The main objectives are to investigate change in diagnosis, diagnostic certainty and patient management, due to BBM results.",[27,28],"Alzheimer Blood Biomarkers","Alzheimer's Disease (AD)",[30],"Randomised diagnostic trial","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2025-09-17",{"date":39,"type":21},"2027-06-30",{"name":41,"class":42},"Alzheimercentrum Amsterdam","OTHER",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100644106","blood-based-biomarkers-for-alzheimers-disease-at-the-primary-care-level-100644106","NCT07666113","Blood-based Biomarkers for Alzheimer's Disease at the Primary Care Level.","The Diagnostic Validity and Clinical Impact of Blood-based Biomarkers for the Diagnosis of Alzheimer's Disease at the Primary Care Level.","ADPriK","Inclusion Criteria:\n\n* Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status.\n\nExclusion Criteria:\n\n* Comorbidities that would interfere with study cooperation or interpretability of study results (for instance substance abuse or cardiac, renal or hepatic failure).\n* Concomitant medications that would interfere with cognitive assessments.\n* A prior diagnosis of AD and related disorders or other neurodegenerative disease.",true,"85 Years",{"count":55,"type":21},240,[24],"The goal of this study is to determine how blood biomarker tests (ptau217 and ptau217\u002FAβ42) performed in primary care influence the patient trajectory in individuals with cognitive concerns.\n\nParticipants will provide a blood sample for biomarker testing and undergo clinical assessments as part of diagnostic evaluation.",[28],"2026-06-17",{"date":61,"type":35},"2026-06-24",{"date":63,"type":35},"2026-05-26",{"date":65,"type":21},"2038-04",{"name":67,"class":42},"Universitaire Ziekenhuizen KU Leuven",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":68},"100625679","adapting-rdad-for-ds-100625679","NCT07425769","Adapting RDAD for DS","Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test","CareFit DS\u002FAD","Inclusion Criteria - Adults with Down syndrome:\n\n* Age \\>35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \\~31 in adults with DS.\n* Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.\n* Living at home or in a supported living environment with a parent\u002Fcaregiver who agrees to serve as a study partner.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Adults with Down syndrome:\n\n* Unable to participate in moderate-to-vigorous physical activity.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.\n\nInclusion Criteria - Caregivers\n\n* Age ≥18 yrs.\n* Reports being a primary caregiver of an adult with DS.\n* English speaking.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Caregivers\n\n* Unable to participate in moderate PA, i.e., brisk walking.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.",{"count":78,"type":21},40,[24],"The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.",[82,28],"Down Syndrome (DS)","2026-05-05",{"date":85,"type":35},"2026-05-06",{"date":87,"type":35},"2026-03-31",{"date":89,"type":21},"2026-07-31",{"name":91,"class":42},"University of Kansas Medical Center",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":68},"100484793","in-dementia-clinical-trials-100484793","NCT05592678","δ in Dementia Clinical Trials","Novel Methods for Clinical Trials in Dementia and Cognitive Decline","δND","Inclusion Criteria:\n\n1. Ambulatory outpatient volunteers with co-informants.\n2. Aged 65-100 years\n3. Clinical diagnosis of AD, or MCI.\n4. Capacity to give informed consent.\n5. GDS score (15 item) ≤ 8.\n6. No significant visual or hearing impairments\n7. Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.\n\nExclusion Criteria:\n\n1. A history of psychosis, including visual hallucinations;\n2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;\n3. History of bradycardia or syncopal events;\n4. Treatment for cancer in the last 5 years (excluding skin cancers);\n5. Major surgery in the last year;\n6. Treatment for a seizure disorder with anticonvulsants;\n7. Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);\n8. Current treatment with donepezil or any other AChEI or exposure within the last six months\n9. With a recently started Donepezil Rx (\\\u003C 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.\n10. AChEI treatment not appropriate due to negative risk\u002Fbenefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.\n11. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.","65 Years","100 Years",{"count":103,"type":21},200,[24],"The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are:\n\n* Can an intervention's outcome be better assessed by a latent variable (\"δ\") integrating cognitive performance with functional status?\n* Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity?\n* Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention?\n* Is the effect of the intervention in fact medicated by changes in the targeted biomarker?\n\nIn this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called \"adipokines\"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes.\n\nParticipants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.",[28,107,108,109],"Dementia","Cognitive Decline","Mild Cognitivie Impairment (MCI)",[111,112,113,114,115],"adipokines","cognition","dementia","functional status","intelligence","2026-04-30",{"date":83,"type":35},{"date":119,"type":35},"2024-08-05",{"date":121,"type":21},"2028-11-30",{"name":123,"class":42},"The University of Texas Health Science Center at San Antonio",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":52,"sex":17,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100636619","phase-1-phase-1-study-to-evaluate-the-safety-and-tolerability-of-8m2d-in-healthy-people-and-alzheimers-patients-100636619","NCT07568041","Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's Patients","A Phase Ia (SAD\u002FMAD), Randomized, Double-Blind, Placebo-Controlled Trial and Phase Ib Open-Label Trial to Evaluate Safety, Tolerability, PK, and Exploratory Immunogenicity of Single and Multiple Doses of 8M2D in Healthy Participants and Early AD Participants.","Inclusion Criteria:\n\nPart I (Single Ascending Dose) and Part II (Multiple Ascending Dose):\n\n1. Voluntarily consents to participate in this trial and provides written informed consent before the start of any trial assessments.\n2. Healthy male and female adults, 18 and 55 years of age (inclusive).\n3. Participants with a body mass index (BMI) ≥ 18 and ≤ 32 kg\u002Fm2 (inclusive) and weigh a minimum of 50 kg.\n4. Participants with a normal 12-lead ECG at Screening.\n5. Participant has normal renal function.\n6. Females participants must meet one of the following criteria:\n\n   a. Females must either be of non-childbearing potential, or if of childbearing potential, must agree to use contraceptives throughout the study period and have a negative pregnancy test at both Screening and Check-in (Day -1).\n7. Males with a sexual partner who is a female of childbearing potential must be surgically sterile, or agree to use condoms with spermicide or abstain from sexual intercourse, starting from Screening until 90 days after the last dose of the trial medication.\n8. Participant is willing and able to complete all trial assessments in compliance with the protocol and is able to remain in the inpatient treatment unit for the entire duration of the confinement period and return for outpatient visits.\n\nPart III Alzheimer's Disease:\n\n1. Participant is able to provide written informed consent prior to the performance of any trial -specific procedures.\n2. Male or female participants with early Alzheimer's disease between 55 and 80 years of age (inclusive) in good health as determined by the Investigator.\n3. Participants with a BMI of ≥ 18.0 and ≤ 32.0 kg\u002Fm2 (inclusive) and weigh a minimum of 50 kg.\n4. Participants with a 12-lead ECG at screening which, in the opinion of the Investigator, has no abnormalities that compromise participant's safety in this study.\n5. Females participants must meet one of the following criteria:\n\n   a. Females must either be of non-childbearing potential, or if of childbearing potential, must agree to use contraceptives throughout the study period and have a negative pregnancy test at both Screening and Check-in (Day -1).\n6. Males with a sexual partner who is a female of childbearing potential must be surgically sterile, or agree to use condoms with spermicide or abstain from sexual intercourse, starting from Screening until 90 days after the last dose of the trial medication.\n7. Participant is willing and able to complete all trial assessments in compliance with the protocol and is able to remain in the inpatient treatment unit for the entire duration of the confinement period and return for outpatient visits.\n8. Participant meets the diagnostic criteria of mild cognitive impairment (MCI) of probable Alzheimer's disease consistent with National Institute On Aging - Alzheimer's Association (NIA-AA) research framework.\n9. Participant with a qualifying amyloid score.\n10. Participant with a Mini-Mental State Examination (MMSE) score between 20 and 28 inclusive at screening and baseline.\n\nExclusion Criteria:\n\nPart I (Single Ascending Dose) and Part II (Multiple Ascending Dose):\n\n1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the trial results.\n2. Participant has abnormal laboratory values detected at Screening or on clinic admission (Day -1) that suggest a clinically significant underlying disease.\n3. Participant who shows evidence of suicidal ideation as assessed by the C-SSRS at screening and at Day -1 or history of suicide attempt (lifetime).\n4. Participant with positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) at Screening.\n5. Participant smokes cigarettes or uses other nicotine-containing products in the past 3 months prior to Screening.\n6. Participant with regular alcohol consumption within 6 months prior to the trial defined as an average weekly intake of \\> 20 units for males or \\> 16 units for females (8g ethanol = 1 unit).\n7. Participant tests positive in the urine test for alcohol, cotinine, and\u002For screen for drugs of abuse at the time of screening or Day -1.\n8. Participant with a history of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM V criteria or later) within the 2 years prior to study entry.\n9. Participation in any clinical trial and\u002For recipient of investigational trial medication within 90 days prior to the first dose of 8M2D.\n10. Participant with a loss of ≥ 500 mL (1 unit) of blood within 90 days prior to receiving the first dose of 8M2D.\n11. In addition to the above criteria, those judged by the Investigator as not suitable for participating in this clinical trial\n\nPart III Alzheimer's Disease:\n\n1. Participant with history or presence of any uncontrolled systemic disease (e.g., hypertension (systolic BP ≥ 150 mmHg\u002Fdiastolic BP ≥ 100 mmHg), diabetes mellitus (HbA1c ≥ 8% at the time of screening) etc.).\n2. Participant with history or presence of unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney, or liver disease.\n3. Participant with any active or unstable clinically significant medical or psychiatric condition as judged by the Investigator.\n4. Participant who has current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the Investigator's opinion, could interfere with the analyses of safety and efficacy in this trial.\n5. Participant with any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.\n6. Participant with history within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate specific antigen post-resection.\n7. Participant with history of intracranial hemorrhage, cerebrovascular aneurysm, or arteriovenous malformation, carotid artery occlusion, stroke, or epilepsy.\n8. Participant who shows evidence of suicidal ideation as assessed by the C-SSRS at screening and at Day -1 or history of suicide attempt (lifetime).\n9. Participant with positive serology for HBsAg, HBcAb, HCV, or HIV at Screening.","18 Years","80 Years",{"count":134,"type":21},54,[136],"PHASE1","This study is testing a new investigational drug called 8M2D to learn whether it is safe and well-tolerated in humans. 8M2D has not previously been given to people.\n\nHypothesis: Researchers believe that 8M2D can be administered safely to healthy adults and to people with early Alzheimer's disease, and that it may reduce levels of amyloid beta. Amyloid beta is a protein that builds up in the brains of people with Alzheimer's disease and is thought to contribute to its progression.\n\nThe study will be conducted in three parts. In the first two parts, healthy volunteers will receive either a single dose or multiple doses of 8M2D so researchers can understand how the drug moves through the body and whether it causes any side effects. In the third part, a small group of people with early Alzheimer's disease will receive multiple doses so researchers can also begin to assess whether the drug has any effect on amyloid beta levels.\n\nDoses will be increased gradually and carefully. An independent safety board will review safety information before any dose increase is allowed. The information gathered in this study will be used to identify the appropriate dose of 8M2D and to help design future studies in people with Alzheimer's disease.",[28],[140,141,142,143,144,145,146,147,148,149],"Alzheimer's disease","amyloid beta","Alzheimer's disease treatment","Alzheimer's disease prevention","Phase 1a\u002Fb clinical trial","Single Ascending Dose","Multiple Ascending Dose","first-in-human","safety, tolerability, and pharmacokinetics","exploratory immunogenicity","NOT_YET_RECRUITING","2026-04-28",{"date":83,"type":35},{"date":154,"type":21},"2026-09-15",{"date":156,"type":21},"2027-12",{"name":158,"class":159},"Cenna Biosciences Inc.","INDUSTRY",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":52,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":68},"100633617","acoustic-stimulation-during-sleep-effects-on-memory-and-p-tau217-in-mci-100633617","NCT07529015","Acoustic Stimulation During Sleep: Effects on Memory and p-tau217 in MCI","The Impact of Phase-locked Acoustic Stimulation on Sleep Structure, Memory Consolidation, and Plasma p-tau217 in Patients With Mild Cognitive Impairment","PAS-MCI","Inclusion Criteria:\n\n* Diagnosis of aMCI according to the NIA-AA criteria (Albert et al., 2011) and positive state of plasma p-tau217.\n* Diagnosis of aMCI according to the NIA-AA criteria (Albert et al., 2011) and negative state of plasma p-tau217 for aMCI negative group.\n* Cognitively unimpaired older subjects aged ≥ 65 years, Mini-mental state examination ≥28, and negative for plasma p-tau217.\n\nExclusion Criteria:\n\n* Diagnosis of dementia due to AD or any other type of dementia.\n* Presence of any diagnosed sleep disorder such as narcolepsy, severe insomnia, severe obstructive sleep apnea, or severe chronic lack of sleep.\n* Hearing problems.\n* Analphabet individuals.\n* Comorbidities such as cancer, severe depression, severe renal or hepatic insufficiency, history of seizures, and severe cardiac or respiratory failure.\n* Alcohol and substance abuse.\n* Magnetic resonance imaging (MRI) evidence of stroke, hydrocephalus, a space-occupying lesion, or any clinically relevant central nervous system disease.\n* Existence of untreated (or treated for less than 3 months prior to the screening visit) vitamin B12 or folate deficiency.\n* Presence of untreated thyroid disease.\n* Use of betablockers, antidepressants, neuroleptics, and hypnotics, within 15 days before conducting polysomnography.","60 Years",{"count":170,"type":21},114,[24],"The goal of this clinical trial is to determine whether acoustic stimulation during sleep can enhance slow-wave sleep (SWS), improve cognitive function, and reduce AD-related pathology in individuals with mild cognitive impairment (MCI), compared with cognitively healthy participants.\n\nThe main questions it aims to answer are:\n\n1. Does acoustic stimulation increase SWS (e.g., slow oscillation and sleep spindle activity) in individuals with MCI?\n2. Does enhancing SWS lead to improvements in memory and cognitive performance?\n3. Does acoustic stimulation influence plasma p-tau217 levels as a marker of underlying Alzheimer's disease pathology? Researchers will compare participants receiving acoustic stimulation during sleep with those not receiving stimulation to evaluate its effects on sleep architecture, cognition, and plasma biomarkers.\n\nParticipants will:\n\n* Undergo sleep recordings to assess sleep architecture, including SWS, slow oscillations, and sleep spindles\n* Receive acoustic stimulation during sleep across multiple nights\n* Complete cognitive assessments, particularly memory-related tasks\n* Provide blood samples to measure plasma p-tau217 levels\n* Provide clinical and demographic information for analysis",[28,174,175],"Mild Cognitive Impairment (MCI) Amnestic","Cognitively Unimpaired",[140,177,178,179,180,181,182,183,184,185],"acoustic stimulation","declarative memory","amnestic mild cognitive impairment","sleep spindle","episodic memory","sleep EEG","slow-wave sleep","p-tau217","slow oscillation","2026-04-07",{"date":188,"type":35},"2026-04-14",{"date":190,"type":21},"2026-04",{"date":192,"type":21},"2028-12",{"name":194,"class":42},"Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":52,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":68},"100619160","evaluation-of-a-neuropsychological-tool-to-assess-temporal-processing-abilities-in-alzheimers-disease-100619160","NCT07341009","Evaluation of a Neuropsychological Tool to Assess Temporal Processing Abilities in Alzheimer's Disease","CHRONOS","Inclusion Criteria:\n\n* No objection from the participant or their legal representative, if applicable, prior to or during the assessment\n* Deficit in at least two cognitive functions, including episodic memory.\n\nExclusion Criteria:\n\n* History of head trauma with loss of consciousness lasting more than 1 hour\n* Presence of clinically significant major psychiatric disorders (according to DSM-IV-TR criteria)\n* Use of medications likely to alter cognitive and\u002For brain function (decision by the principal investigator)",{"count":78,"type":21},"OBSERVATIONAL","Perceiving and representing the passage of time allows us to temporally organize perceptions and memories for the coordination of actions, planning, and the mobilization of cognitive processes toward a goal. This innovative project aims to clarify the profile of time impairment associated with normal aging and the progression of age-related pathologies. This project proposes to develop a new neuropsychological tool for quantifying and preventing changes in the relationship to time associated with Alzheimer's disease. Four aspects of time are distinguished, which are measured separately and distributed along a continuum between perception and memory: (a) perception of simultaneity and order; (b) processing of durations; (c) subjective sense of the passage of time; and (d) mental time travel. Crucially, many neurological and psychiatric disorders are associated with impairment in one or more aspects of time. However, time remains largely unexplored in clinical practice. Patients with Alzheimer's disease will complete the CHRONOS battery. This battery allows for a rapid assessment (approximately ten minutes) of the four aspects of time. This new battery will enable the identification of behavioral markers aimed at improving prognosis and prevention regarding individual cognitive trajectories of aging. The relationship to time is closely linked to each person's personal experience. This project will help to put into words difficulties that are not always expressed in terms of time. Thus, considering these pathologies from the perspective of time aims to better understand and prevent their difficulties and to guide the identification of new markers and new avenues for remediation.",[28,206],"Time Perception",[208,113,112,209],"temporal cognition","neuropsychology","2026-03-17",{"date":212,"type":35},"2026-03-19",{"date":214,"type":35},"2025-12-30",{"date":216,"type":21},"2027-11-01",{"name":218,"class":42},"University Hospital, Caen",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":52,"sex":17,"minAge":131,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":68},"100482183","social-cognitive-functioning-validation-of-a-new-neuropsychological-test-100482183","NCT05558709","Social-cognitive Functioning: Validation of a New Neuropsychological Test","Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life","REALSOCOG","Inclusion Criteria:\n\nFor patients:\n\n* Patient aged between 18 and 90 years\n* Mini Mental State Examination (MMSE) score greater than or equal to 20\n* Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner\n* Patient with a neurodegenerative pathology: FTD, AD or LBD.\n\nFor caregivers:\n\n* Over 18 years of age\n* Regular contact with the patient (≥ 2 times per month)\n\nExclusion Criteria:\n\nFor patients:\n\n* Neurological or psychiatric comorbidity\n* Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion.\n* Opposition to participation in the study","90 Years",{"count":229,"type":21},120,[24],"It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).",[28,233,234],"Lewy Body Dementia (LBD)","Frontotemporal Degeneration (FTD)",[236,237,238,239],"Neurodegenerative diseases","Social behavior","Social cognition","Neuropsychological assessment","2026-03-11",{"date":242,"type":35},"2026-03-13",{"date":244,"type":35},"2026-02-04",{"date":246,"type":21},"2030-02-04",{"name":248,"class":42},"Assistance Publique - Hôpitaux de Paris",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":52,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":68},"100628803","cogscreen-ii-early-detection-of-cognitive-impairment-100628803","NCT07466394","COGSCREEN II: Early Detection of Cognitive Impairment","German: COGSCREEN II: Früherkennung Kognitiver Störungen Durch Screeningverfahren Von Haus- Und Fachärzten Bei Senioren in Deutschland English: COGSCREEN II: Early Detection of Cognitive Impairment Through Screening Procedures by General Practitioners and Specialists in Older Adults in Germany (DAC AccDx Munich Site)","COGSCREEN II","Inclusion Criteria:\n\n* Male or female ≥ 60 years of age at the time of consent\n* Able to understand and voluntarily sign an informed consent according to the judgment of the practice team\n\nExclusion Criteria:\n\n* Subjects who are unable to hear or see well enough to complete the assessments\n* Prior diagnosis of dementia (with or without evidence of pathology) as documented in the medical record and\u002For diagnosed by a physician",{"count":258,"type":21},400,[24],"While knowledge about dementia and its causes is increasing rapidly, healthcare systems remain ill-equipped to detect cognitive decline in the early stages of neurodegenerative diseases such as Alzheimer's disease (AD). However, improving the early identification of AD in the population is a prerequisite for dementia prevention and providing future disease-modifying treatments for individuals most likely to benefit. Subjective cognitive deficits (SCD) and mild cognitive impairment (MCI) may indicate prodromal AD, even in the absence of functional impairment; in conjunction with an AD-typical biomarker profile (such as abnormal protein markers in the cerebrospinal fluid, CSF), the risk of further cognitive decline increases significantly. Offering cognitive screening to individuals with SCD or MCI may therefore open a window of opportunity for early interventions.\n\nCurrently, there is no system in place for targeted, standardized identification of cases with minimal cognitive decline in Germany or worldwide, hindering efforts to detect neurodegenerative and other causes of cognitive impairment in large segments of the population. The lack of a robust approach for detecting early changes with acceptable accuracy outside of specialist clinics results in disappointingly low diagnostic rates. This is despite evidence showing that structured case finding programs can significantly improve the early detection of cognitive decline.\n\nThis project will build on an existing network of general practitioners (GPs) and specialists in private practice (neurologists, psychiatrist and geriatricians). The investigator's efforts will aim to strengthen and expand this network, resulting in a larger pool of doctors in the community who have specialized knowledge and a strong commitment to the care of people with dementia. Over the course of the project, the investigators will introduce participating physicians to proprietary digital cognitive tests and blood-based biomarkers (provided by Roche). Building on the success of the ongoing COGSCREEN project, which deploys a community-based recruitment strategy (project number 22-0786), this initiative will equip the Munich healthcare system with the necessary tools to effectively identify individuals most likely to benefit from upcoming disease-modifying treatments for AD. This will serve as a template for the implementation of a precision medicine approach to early diagnosis of AD in Germany and beyond.",[28],"2026-03-07",{"date":264,"type":35},"2026-03-12",{"date":266,"type":35},"2025-06-01",{"date":268,"type":21},"2027-07-01",{"name":270,"class":42},"Robert Perneczky",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":68},"100628206","phase-1-prospective-single-arm-safety-study-of-cervical-lva-in-ad-patients-100628206","NCT07458620","Prospective Single-Arm Safety Study of Cervical LVA in AD Patients","Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients With Alzheimer's Disease","Neck LVA","Inclusion Criteria:\n\n* Diagnosis of Alzheimer's Disease: Participants must have a confirmed diagnosis of Alzheimer's Disease as evaluated by a neurologist and a psychiatrist at the hospital.\n* Positive Amyloid-PET Scan: The result of a \\[18F\\] Florbetapir (Amyloid-PET) scan must be positive, indicating the presence of amyloid plaques in the brain.\n* Willingness to Consent: Participants or their legal representatives must be willing to sign a written informed consent form.\n* Participants must be adults aged 18 years or older\n\nExclusion Criteria:\n\n* Lack of Informed Consent: Potential participants are excluded if they are unable to exercise autonomy and informed consent cannot be obtained from a legal representative or authorized person.\n* Prior Surgical History: Individuals who have previously undergone neck lymphatic dissection, nasopharyngeal surgery, or intracranial surgery are excluded.\n* Concurrent Medical Conditions: The trial excludes persons with thyroid disease or chronic heart failure.\n* Specific Allergies: Candidates with a history of allergies to shellfish or iodine are excluded due to the use of Indocyanine Green (ICG) during the procedure.\n* Unresolved Concerns: Anyone who has doubts about the trial and cannot receive satisfactory answers is excluded.\n* Anesthesia Risks: Individuals deemed medically unfit for general anesthesia-for example, those with severe cardiopulmonary insufficiency or a history of specific anesthetic drug allergies-are ineligible.",{"count":280,"type":21},35,[136],"Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease\n\nPurpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with Alzheimer's Disease.\n\nHow the Surgery Works Alzheimer's Disease is linked to the buildup of metabolic waste products (certain proteins) in the brain. Recent medical discoveries show that these wastes normally drain through small channels in the neck into the blood system. In this study, surgeons will use high-powered microscopes to connect these drainage channels (lymphatic vessels) in the neck directly to small nearby veins. The goal is to create a \"detour\" that helps the brain clear out these harmful proteins more effectively.\n\nWhat to Expect Safety First: The main goal is to find out if the surgery is safe and well-tolerated by patients.\n\nThe Procedure: The surgery is performed under general anesthesia and typically takes 4 to 6 hours. It involves small (about 5 cm) incisions on both sides of the neck.\n\nFollow-up: Participants will be monitored for at least 12 months. Researchers will use memory tests, brain scans (MRI and PET), and blood tests to see if the surgery helps with daily activities or slows down memory loss.",[28],[28,285,107,286,287,288,289,290,291,292,293,294,295,296],"Neurodegenerative Diseases","Lymphaticovenular Anastomosis (LVA)","Supermicrosurgery","Cervical Lymphatic Bypass","Glymphatic System Clearance","Meningeal Lymphatic System","Amyloid-beta (Aβ) Drainage","Tau Protein Clearance","CSF","Deep Cervical Lymph Nodes (dCLNs)","Amyloid-PET Imaging","Indocyanine Green (ICG) Lymphography","2026-03-04",{"date":299,"type":35},"2026-03-09",{"date":301,"type":21},"2026-03",{"date":303,"type":21},"2028-09",{"name":305,"class":42},"Chang Gung Memorial Hospital",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":52,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":68},"100625160","improv-music-therapy-for-older-adults-100625160","NCT07419022","Improv Music Therapy for Older Adults","Impact of Improvisation Music Therapy for Persons Living With Dementia and Their Care Partners","Inclusion Criteria\n\nInclusion criteria for the Person Living with Dementia (PLWD) are:\n\n* Age 60 and over, living independently in the community\n* Medical diagnosis of Alzheimer's Disease\n* Mild dementia defined as MoCA score between 16-20, or MMSE score between 19-24\n* Sufficient visual and hearing acuity (age-related to normal hearing loss with assistive devices)\n* English fluency rated fairly well to well (self-rated English fluency)\n\nInclusion Criteria for Caregiver are:\n\n* Age 18 or Older\n* Moderate to good English fluency (self-rated English fluency)\n* Willing to participate in intervention with PLWD\n\nExclusion Criteria\n\nExclusion criteria for PLWD are:\n\n* Medical diagnosis of severe dementia (any etiology)\n* Non-AD dementia diagnosis (e.g., frontotemporal dementia)\n* Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study\n* Significant difficulty moving the hands or arms (severe arthritis, neuropathy)\n* Plans to move out of the area within six months\n\nExclusion criteria for Caregiver are:\n\n* Current but not prior severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)\n* Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study\n* Plans to move out of the area",{"count":78,"type":21},[24],"Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.",[28,317],"Older Adults (65 Years and Older)",[319,320,321,322,323,324,325,326],"music","improvisation","person living with dementia","caregiver","Alzheimer's Disease and related diseases","mechanism of behavior change","stress reduction","behavior change","2026-02-20",{"date":329,"type":35},"2026-02-23",{"date":331,"type":21},"2026-12",{"date":192,"type":21},{"name":334,"class":42},"University of California, San Francisco",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":52,"sex":17,"minAge":131,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":350,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":364,"locationsCount":68},"100622175","quantification-of-hsp90-in-the-human-brain-100622175","NCT07380204","Quantification of Hsp90 in the Human Brain","In Vivo Quantification of Hsp90 in the Human Brain in Healthy Aging and Neurodegeneration Using the Novel PET Radioligand [11C]HSP990","Inclusion Criteria:\n\nHealthy controls\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n* Male or female subjects, age between 18-55 (Part 1, n = 3), 18-40 (Part II, n = 5) or 40-70 (Part III, 40-55 n = 5, 55-70 n = 5) years old.\n* Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.\n* No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment (SCL-90).\n* (Part II and III only: ) In subjects \\\u003C 60 years of age, a normal structural MRI scan as assessed by expert radiologist. In subjects \\>= 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \\\u003C 2 on the Age-Related White Matter changes scale are acceptable\n\nParkinson's disease\n\n* Age 45-85 years.\n* Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria and is in Hoehn-Yahr stage I-III in the \"on\" medication state\n* Patient has had a previous abnormal DaT-scan confirming the clinical diagnosis.\n* Patient is able to understand the patient information brochure and give written informed consent\n\nAlzheimer's disease\n\n* Age 45-85 years.\n* MoCA score \\\u003C 26\n* Patient has a diagnosis of probable AD with evidence of the AD pathophysiological process (amyloid PET scan or CSF determination) according to the consensus criteria \\[McKahn et al 2011, Alzh Dement\\].\n* Patient is able to understand the patient information brochure and give written informed consent.\n\nAmyotrophic lateral sclerosis\n\n* Age 20-85 years.\n* Subjects will be recruited at the Neurology department of University Hospitals Leuven and must meet revised El Escorial Criteria and Awaji-Shima criteria for at least possible ALS.\n* Patient is able to understand the patient information brochure and give written informed consent.\n\nExclusion Criteria:\n\nHealthy controls\n\n* Participant has a history of any major disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator (especially diabetes mellitus, heart disease, liver and kidney disease, or most forms of cancer).\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial .\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device.\n* Evidence of cognitive impairment.\n* Subject has a history or evidence of psychiatric disease.\n* Subject has renal impairment with eGFR \\\u003C 60 ml\u002Fmin.\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* (Part II and III only: ) Subject has a contra-indication for MRI scanning.\n* Subject has a known hypersensitivity to any of the excipients that are present in the radiopharmaceutical preparations or to any of the excipients listed in the IMPD for \\[11C\\]HSP990.\n* Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures. Subject cannot lie still for at least 70 minutes inside a scanner.\n* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning;\n* Subject 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 pregnant (according to Ulti Med hCG urine test) or is breastfeeding.\n* Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP: contraception methods with a relatively high Pearl index (natural methods, minipill outside postpartum period, spermicides or condoms in monocontraception or no usage of contraception when sexually active) are not accepted.\n* Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.\n* Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him\u002Fherself.\n* (Part II and III only: ) An abnormal Allen test or hypersensitivity\u002Fallergy to lidocaine.\n* (Part II and III only: ) Anticoagulant therapy is an exclusion criterium for undergoing arterial sampling as part of the study. Subjects that have anticoagulant therapy can participate in the study parts without arterial sampling.\n\nParkinson's disease:\n\n* Neuropsychiatric diseases other than the cohort inclusion condition\n* Major internal medical comorbidity, in particular diabetes or heart disease\n* Subject has renal impairment with eGFR \\\u003C 60 ml\u002Fmin.\n* White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities\n* History of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug use\n* Contraindications for MR\n* Subject has a known hypersensitivity to any of the excipients that are present in the radiopharmaceutical preparations or to any of the excipients listed in the IMPD for \\[11C\\]HSP990.\n* Subject suffers from claustrophobia or cannot tolerate confinement during PET scanning procedures; subject cannot lie still for 70 minutes inside the scanner.\n* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.\n* Subject does not understand the study procedures or does not have a guardian who understands the study procedures.\n* Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.\n* Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him\u002Fherself.\n* Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.\n* Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP\\* : contraception methods with a relatively high Pearl index (natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active) are not accepted.\n* Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.\n* Anticoagulant therapy is an exclusion criterium for undergoing arterial sampling as part of the study. Subjects that have anticoagulant therapy can participate in the study parts without arterial sampling.\n\nAlzheimer's disease:\n\n\\- cf. Parkinson's Disease exclusion criteria\n\nAmytorphic lateral sclerosis:\n\n* cf. Parkinson's Disease exclusion criteria\n* Subject has confined upper motor neuron involvement (i.e. primary lateral sclerosis) or confined lower motor neuron involvement (i.e. progressive muscular atrophy).","70 Years",{"count":344,"type":21},48,[24],"This study tests the radiolabeled molecule (\"tracer\"), \\[¹¹C\\]HSP990, using positron emission tomography (PET) imaging to assess whether it can be used to measure levels of Heat Shock Protein 90 (Hsp90). The protein Hsp90 plays an important role in how proteins in the brain fold into their three-dimensional structure and how this protein helps maintain cellular homeostasis. Since neurodegenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), and amyotrophic lateral sclerosis (ALS) are characterized by disrupted three-dimensional protein folding resulting in protein aggregation, we also aim to measure Hsp90 levels in patients with these conditions.\n\n\\[¹¹C\\]HSP990 is a promising tracer for this purpose and has already been extensively tested in animal models with safe and favorable results. The investigator now aims to evaluate this tracer in the human brain in healthy volunteers as well as in patients with Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis. The investigator expects that Hsp90 protein levels will be present at reduced concentrations in patients, possibly in different brain regions depending on the distribution of the disease-causing proteins associated with these disorders.\n\nSince the discovery of the important role of Hsp90 in neurodegenerative diseases, several candidate drugs targeting Hsp90 have been developed in recent years. The imaging method used in this study may support the development of Hsp90-targeting medications by enabling measurement of Hsp90 levels in the brain and assessment of the effects of these drugs.",[348,28,349],"Parkinson's Disease (PD)","Amyotrophic Lateral Sclerosis (ALS)",[351,352,353,354,355,356,357],"HSP90","PET","test-retest","dosimetry","Parkinson","Alzheimer","ALS","2026-01-26",{"date":360,"type":35},"2026-02-02",{"date":362,"type":35},"2024-09-04",{"date":156,"type":21},{"name":67,"class":42},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"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":374,"type":21},286,[24],"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.",[378,28],"Dementia With Lewy Bodies (DLB)","2025-09-08",{"date":381,"type":35},"2025-09-10",{"date":383,"type":21},"2026-01-01",{"date":385,"type":21},"2032-01-01",{"name":387,"class":42},"University Hospital, Strasbourg, France",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":396,"maxAge":53,"enrollmentInfo":397,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":68},"100443803","amyloid--clearance-mechanisms-in-alzheimers-disease-100443803","NCT05059158","Amyloid-β Clearance Mechanisms in Alzheimer's Disease","Amyloid-β Clearance Mechanisms: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function in Alzheimer's Disease","AmyClearAD","Inclusion Criteria:\n\n* Diagnosis of amnestic MCI or AD dementia or clinical normal\n* Able to provide written informed consent\n* Unchanged pharmacotherapy within 4 days prior to the study specific assessments\n* Fluent in German\n\nExclusion Criteria:\n\n* Unable to give informed consent or has a legal guardian\n* Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder\n* Clinically relevant depression\n* Acute suicidality\n* Current alcohol, drug or medication abuse\n* History of severe traumatic brain injury within 3 months prior to inclusion\n* Structural lesions of the basal ganglia or brain stem\n* Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus\n* Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension\n* Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication\n* Renal failure \\> stage 3 (GFR \\\u003C 30 mL\u002Fmin)\n* Pregnancy\n* Unresolved malignancies within two years prior to inclusion\n* Severe current infections or other chronic or systemic disorders\n* Other circumstances which preclude participation based on the investigator's judgement","50 Years",{"count":398,"type":21},60,"The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. In order to achieve this aim the investigators intend to study participants with a Subjective Cognitive Decline, Mild Cognitive Impairment and a mild Alzheimer's disease.",[28],[402,403,404,405,406,407],"Alzheimer's Disease","Mild Cognitive Impairment","Sleep","Actigraphy","Blood-brain-barrier","Amyloid-β Clearance Mechanisms","2025-07-01",{"date":410,"type":35},"2025-07-04",{"date":412,"type":35},"2021-06-01",{"date":414,"type":21},"2025-10",{"name":416,"class":42},"Ludwig-Maximilians - University of Munich",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":52,"sex":17,"minAge":131,"maxAge":227,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":433,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":68},"100592899","phase-1-exploring-the-utility-of-18f3f4ap-for-demyelination-imaging-100592899","NCT06999434","Exploring the Utility of [18F]3F4AP for Demyelination Imaging","Inclusion:\n\n1. Male and Female subjects must be ≥18 and \\\u003C90 years of age;\n2. Able to understand and provide informed consent prior to study procedures\n3. Must be in good health\n\nExclusion:\n\n1. Less than 18 years of age;\n2. Pregnant or breastfeeding;\n3. Any significant systemic illness or unstable medical condition;\n4. Pre-existing medical conditions or claustrophobic reactions;\n5. Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);\n6. History of a bleeding disorder or are currently taking anticoagulants.",{"count":424,"type":21},105,[136],"The overall objective is to obtain an assessment of the pharmacokinetics of \\[18F\\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).",[428,429,28,430,431,432],"Demyelinating Disorders","MCI","MS (Multiple Sclerosis)","SCI - Spinal Cord Injury","Spinal Radiculopathy",[434,428,435,436,437],"3F4AP","MS","SCI","AD","2025-05-22",{"date":440,"type":35},"2025-05-31",{"date":442,"type":35},"2025-05-05",{"date":444,"type":21},"2030-05-05",{"name":446,"class":42},"Yale University",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":52,"sex":17,"minAge":454,"maxAge":342,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":68},"100584620","early-phase-1-18faci-19626-pet-in-tdp-43-proteinopathies-100584620","NCT06891716","[18F]ACI-19626 PET in TDP-43 Proteinopathies","Phase 1 Study to Evaluate [18F]ACI-19626 as a Potential PET Radioligand for Imaging TDP-43 Inclusions in the Brain of Patients With Suspected TDP-43 Proteinopathies Compared With Healthy Controls","Inclusion Criteria for all Participants:\n\n* Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed.\n* Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use reliable contraception method(s) and not donate eggs for 30 days after the PET scan. Subjects without documentation of non-childbearing potential will perform serum pregnancy testing at screening and urine pregnancy test before the PET scan. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the PI (e.g., Müllerian agenesis). Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use a reliable form of birth control (e.g. a barrier, hormonal contraception method or intrauterine device), during the study and until 30 days after the last PET scan. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. Women of childbearing potential must commit to not donate ovum during the study and until 30 days after the last PET scan.\n* Male subjects with their partners of childbearing potential must commit to the use of a barrier method of contraception during the study and until 90 days after the last PET scan.\n* Male subjects must commit to not donate sperm during the study and until 90 days after the last PET scan.\n* Willing and able to cooperate with study procedures.\n* Ability to tolerate lying in the scanner for up to 90 minutes without excessive movements sufficient to cause significant motion artifact on the PET scans, or if necessary up to 120 minutes with a break.\n* For subjects receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line and coagulation (International Normalized Ratio \\[INR\\], Prothrombin Time \\[PT\\] and Partial Thromboplastin Time \\[PTT\\]).\n\nAdditional Inclusion Criteria for Healthy Controls:\n\n* Males and females aged 40-70 years.\n* Healthy with no clinically relevant finding on physical and neurological examination at Screening and upon reporting to the clinic for the \\[18F\\]ACI-19626 Imaging Visit.\n* No family history of TDP-43 proteinopathies, including FTD, ALS, or other early-onset neurological disease associated with dementia and\u002For movement disorders.\n* No personal history of clinically significant neurological and\u002For psychiatric disorders.\n* No evidence of neurodegeneration or other neurological pathology on magnetic resonance imaging (MRI) performed either as part of Screening or on previously acquired MRI scan (within 6 months prior to signing consent).\n* Montreal Cognitive Assessment (MoCA) score ≥ 26.\n* No cognitive or behavioural impairment as judged by the PI.\n\nAdditional Inclusion Criteria for Participants with TDP-43 proteinopathies:\n\n* Males and females aged ≥ 40 years.\n* Subjects diagnosed with any of the following: GRN, C9Orf72 or other mutation carriers with the CDR® plus NACC FTLD-GS of ≥ 0.5; sporadic probable behavioral FTD per International consensus criteria or primary progressive aphasia, with or without clinical or electrophysiological indications of MND; ALS meeting the El Escorial criteria of probable or possible ALS; Other neurodegenerative diseases, e.g. AD or suspected LATE pathology\n* Confirmed genetic status for the subjects with genetic FTD, FTD-MND or ALS (e.g. GRN, C9orf72 or other mutations)\n* For sporadic FTD \u002F FTD-MND subjects: brain MRI consistent with a diagnosis of FTD, with no evidence of focal disease to account for the subject's neurological, cognitive or behavioral symptoms.\n\nExclusion Criteria for All Participants:\n\n* Current or prior history of any alcohol or drug abuse in the past 2 years.\n* Laboratory tests with clinically significant abnormalities and\u002For clinically significant unstable medical condition.\n* Known history of hypersensitivity, including hypersensitivity to the active substances used for \\[18F\\]ACI-19626 or derivatives, or to any of the associated excipients.\n* Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit (including the procedures in this clinical protocol).\n* Pregnant or lactating.\n* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.\n* Unsuitable veins for repeated venipuncture.\n* Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.\n* Treatment with any antihemostasis medication (e.g., warfarin, heparin, thrombin inhibitors, Factor Xa inhibitors, streptokinase, urokinase, tissue plasminogen activators) within 2 weeks of the planned arterial cannula placement (if performed) of either the baseline or retest imaging.\n* Anaemia (for subjects undergoing arterial cannulation) considered clinically significant by the PI\n* Coagulopathies\n* Loss or donation of blood over 500 mL within four months prior to study visits for subjects undergoing arterial cannulation\n* Subject has received an investigational drug within the last 30 days or 5 half-lives prior to the screening assessments, whichever is longer unless there is documented evidence that the subject was treated with placebo only.\n\nAdditional Exclusion Criteria for Participants with TDP-43 proteinopathies:\n\n* Prior participation in DMT clinical trials which could interfere with the TDP-43 protein itself or its metabolism, including but not limited to gene therapy, unless there is documented evidence that the subject was treated with placebo only.\n* MRI scan showing structural evidence of alternative pathology not consistent with TDP-43 proteinopathies which could cause the subject's symptoms.\n* Mutations with known absence of TDP-43 pathology, e.g. SOD1 or FUS.","40 Years",{"count":456,"type":21},45,[458],"EARLY_PHASE1","The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 \\[involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)\\] using a new positron emission tomography (PET) tracer called \\[18F\\]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial.\n\nThe main questions it aims to answer are:\n\n* whether \\[18F\\]ACI-19626 is safe and well tolerated when injected into participants\n* whether \\[18F\\]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique.\n* whether there are differences in the amount of this protein between people with diseases related to TDP-43 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 MRI in some cases).\n* Visit the clinic to receive the tracer \\[18F\\]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected.\n* Receive a phone call from the clinic 2 to 4 days 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, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.",[461,349,462,463,28],"Frontotemporal Dementia (FTD)","TDP-43 Proteinopathies","Suspected Limbic Predominant Age-related TDP-43 Encephalopathy (LATE)","2025-03-18",{"date":466,"type":35},"2025-03-24",{"date":468,"type":35},"2025-01-21",{"date":470,"type":21},"2026-11",{"name":472,"class":159},"AC Immune SA"]