[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632087":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":38,"centralContacts":55,"locations":65,"responsibleParty":82,"collaborators":38,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":38,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":38,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":113,"overallStatus":68,"whyStopped":38,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,17,21,25,29],{"label":9,"type":6,"description":10,"interventionNames":11},"Healthy controls","Participants in this arm are healthy controls undergoing ultra-high-resolution (UHR) PET imaging on the NeuroEXPLORER system using multiple radiotracers (¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240), in combination with 3T MRI. No therapeutic intervention is administered.",[12,13,14,15,16],"Other: UHR PET\u002FCT scan of the brain with ¹⁸F-FDG","Other: UHR PET\u002FCT scan of the brain with ¹⁸F-PE2I","Other: UHR PET\u002FCT scan of the brain with ¹⁸F-SynVesT-1","Other: UHR PET\u002FCT scan of the brain with ¹⁸F-MK6240","Other: 3T MRI imaging of the brain",{"label":18,"type":6,"description":19,"interventionNames":20},"Patient with aMCI","Participants in this arm are patients with biomarker-confirmed amnestic mild cognitive impairment due to Alzheimer's disease undergoing UHR PET imaging using ¹⁸F-FDG and ¹⁸F-MK6240, in combination with 3T MRI. No therapeutic intervention is administered.",[12,15,16],{"label":22,"type":6,"description":23,"interventionNames":24},"Patients with ALS\u002FALS-FTD","Participants in this arm are patients within the ALS and ALS-FTD spectrum undergoing UHR PET imaging using ¹⁸F-FDG, with a subgroup additionally undergoing ¹⁸F-SynVesT-1 PET, in combination with 3T MRI. No therapeutic intervention is administered.",[12,14,16],{"label":26,"type":6,"description":27,"interventionNames":28},"Patients with movement disorders","Participants in this arm include patients with Parkinson's disease, atypical parkinsonism, dementia with Lewy bodies or idiopathic REM sleep behavior disorder undergoing UHR PET imaging using ¹⁸F-FDG, ¹⁸F-PE2I and ¹⁸F-SynVesT-1, in combination with 3T MRI. No therapeutic intervention is administered.",[12,14,16],{"label":30,"type":6,"description":31,"interventionNames":32},"Patients with psychotic disorders","Participants in this arm are patients with adult-onset or very late-onset psychotic disorders undergoing UHR PET imaging using ¹⁸F-FDG, in combination with 3T MRI. No therapeutic intervention is administered.",[12,16],[34,39,43,47,51],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"UHR PET\u002FCT scan of the brain with ¹⁸F-FDG","Ultra-high-resolution PET\u002FCT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-FDG radiotracer to assess glucose metabolism",[9,18,22,26,30],null,{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"UHR PET\u002FCT scan of the brain with ¹⁸F-PE2I","Ultra-high-resolution PET\u002FCT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-PE2I radiotracer to assess dopaminergic activity",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":38},"UHR PET\u002FCT scan of the brain with ¹⁸F-SynVesT-1","Ultra-high-resolution PET\u002FCT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-SynVesT-1 radiotracer to assess synaptic density",[9,22,26],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":38},"UHR PET\u002FCT scan of the brain with ¹⁸F-MK6240","Ultra-high-resolution PET\u002FCT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-MK6240 radiotracer to assess neurofibrillary tangles",[9,18],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":38},"3T MRI imaging of the brain","All participants will undergo 3T MRI, including T1- and FLAIR-weighted sequences for anatomical reference and white matter pathology, neuromelanin-sensitive imaging to assess SN and LC integrity, and multi-shell diffusion-weighted imaging (DWI) for white matter tractography.",[9,18,22,26,30],[56,61],{"name":57,"role":58,"phone":59,"phoneExt":38,"email":60},"Koen Van Laere, Prof. Dr.","CONTACT","+32 16 34 37 11","koen.vanlaere@uzleuven.be",{"name":62,"role":58,"phone":63,"phoneExt":38,"email":64},"Francine Reniers","+32 16 34 37 15","francine.reniers@uzleuven.be",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"UZ Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":75,"coordinates":76},"Point",[77,78],4.70093,50.87959,{"lat":78,"lon":77},[81],{"name":57,"role":58,"phone":59,"phoneExt":38,"email":60},{"type":83,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100632087","ultra-high-resolution-pet-in-aging-neurodegeneration-and-psychotic-disorders-100632087",false,"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).",true,"ALL","18 Years","90 Years",{"count":96,"type":97},300,"ESTIMATED","INTERVENTIONAL",[100],"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.",[103,104,105,106,107,108,109,110,111,112],"Alzheimer Dementia (AD)","ALS - Amyotrophic Lateral Sclerosis","Parkinson s Disease","REM Sleep Behavior Disorder (iRBD)","PSP - Progressive Supranuclear Palsy","MSA - Multiple System Atrophy","Dementia With Lewy Bodies (DLB)","ALS With Frontotemporal Dementia (ALS\u002FFTD)","Adult Onset Psychotic Disorder","Very Late Onset Psychotic Disorder",[114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"PET\u002FCT scan","Alzheimer´s disease","Dementia","Amyotrophic Lateral Sclerosis","Parkinson´s disease","REM sleep behavior disorders","Progressive supranuclear palsy","Multiple System Atrophy","Dementia with Lewy Bodies","Psychotic disorders","Schizophrenia","ALS with frontotemporal dementia","UHR PET","Locus coeruleus","Papez circuit","Thalamic subnuclei","2026-03-27",{"date":132,"type":133},"2026-04-03","ACTUAL",{"date":135,"type":133},"2026-02-13",{"date":137,"type":97},"2029-09",{"name":5,"class":6},1]