Super-Detailed brain scans could reveal early signs of Alzheimer's, Parkinson's, and ALS
NCT ID NCT07509125
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses a new ultra-high-resolution PET scanner to take detailed pictures of the brain and spinal cord in 300 healthy volunteers and people with conditions like Alzheimer's, Parkinson's, ALS, and psychotic disorders. The goal is to understand how small brain regions change with age and disease, which could help doctors diagnose these conditions earlier. Participants will have brain scans and complete memory, mood, and movement tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * WP1: Healthy controls * Age between 18 and 90 years old (15 aged 18-50 years and 25 aged 50 90 years); * 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; * No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment; * No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline; * In subjects \< 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 WML (white matter lesion) score \<= 2 (of 3) on the Age-Related White Matter changes scale are acceptable; * When older than 50 years of age, the volunteer is willing to undergo a p- tau217 blood sample. * WP2: Dementia * Patient has a clinical diagnosis of biomarker-proven prodromal AD * WP3: ALS spectrum * Subject must meet El Escorial Criteria (30) and Awaji-Shima criteria (31) for at least possible ALS; * WP4: Movement disorders * (all): Patient (or legal representative, when applicable) is able to understand the patient information form and give written informed consent. * Parkinson´s disease (PD): * Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria (32); * Patient has an abnormal 18F-PE2I PET; * No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline. * Multiple system atrophy (MSA) * Patient has clinically established or clinically probable MSA-P based on the * Movement Disorder Society (MDS) diagnostic criteria (33); * Patient has an abnormal 18F-PE2I PET. * Progressive supranuclear palsy (PSP) * Patient has an abnormal 18F-PE2I PET; * Patient has clinically established probable PSP according to the latest MDS criteria * Dementia with Lewy bodies (DLB) * Patient has probable DLB by consensus criteria (cognitive impairment MoCA \< 26 + visual hallucinations and/or fluctuating alertness); * Patient has an abnormal 18F-PE2I PET. * Idiopathic REM sleep behavior disorder (iRBD) * Patient has Polysomnography-confirmed iRBD; * No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline; * No clinical evidence of parkinsonism at baseline. * WP5: Psychosis * DSM 5 criteria for a non-affective schizophrenia spectrum psychotic disorder; * 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. Exclusion Criteria: * 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); * Subject is currently a user (including recreational use) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse; * 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); * Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months; * Subject has a contra-indication for MRI scanning; * 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; * (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; * Subject (or his/her legal representative) does not understand the study procedures; * Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator; * Subject is potentially pregnant (hCG test can be done if doubt exists).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UZ Leuven
RECRUITINGLeuven, Vlaams-Brabant, 3000, Belgium
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Other studies related to the condition(s) this trial covers.
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