Taking people in BelgiumNo phase

High-detail PET brain scans to study aging and brain diseases

Uses detailed PET and MRI brain scans in healthy adults and people with brain disorders.

Key facts

Who runs it: Universitaire Ziekenhuizen KU Leuven
Where: Leuven, BelgiumSee the site
Trial code: NCT07509125
Registry title: Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders
Status: Recruiting
People taking part: 300 people, planned
Started: 13 Feb 2026
Expected to end: Sept 2029
Type of study: Interventional, 5 groups
Treatments tested: UHR PET/CT scan of the brain with ¹⁸F-FDG
UHR PET/CT scan of the brain with ¹⁸F-PE2I
UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1
UHR PET/CT scan of the brain with ¹⁸F-MK6240
3T MRI imaging of the brain
Record updated: 3 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adults and for people with Alzheimer's disease at an early stage, ALS, Parkinson's disease and related movement disorders, or psychotic disorders. All have brain scans (PET and MRI).

Age: 18 to 90 years. Healthy volunteers: 15 aged 18-50 and 25 aged 50-90. Psychosis: 18-55 for adult-onset, over 60 for very late onset.
Sex: All sexes can join.
Disease stage: Healthy volunteers; early (prodromal) Alzheimer's disease proven by a biomarker; at least possible ALS; Parkinson's disease, MSA-P, PSP, DLB or REM sleep behavior disorder as defined by the criteria; non-affective schizophrenia-spectrum psychosis.
Earlier treatment: No exposure to more than 1 mSv of radiation in other research studies in the last 12 months. No long-term use of medicines that act on the brain, other than those prescribed for the illness.
Biomarker or test result: Alzheimer's: a proven biomarker. Parkinson's, MSA, PSP and DLB: an abnormal 18F-PE2I PET. Healthy people over 50 must be willing to give a p-tau217 blood sample.

Main reasons for not taking part

Other major internal, psychiatric or neurological disease that may interfere with the scans
Current illicit drug use, or a history of drug or alcohol abuse
Cannot have an MRI scan, or cannot lie still in the scanner for 60 minutes
Claustrophobia
Possibly pregnant

The registry criteria, word for word

Show all 45 criteriaShow less

Who can take part

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

Who cannot take part

Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months
(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 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 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
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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 90 years old?

Where in Belgium

UZ LeuvenLeuven, BelgiumContact: Koen Van Laere, Prof. Dr.Taking people

About the trial

What the trial wants to find out

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/CT system, a new scanner that can show very small structures in the brain and spinal cord in much more detail than regular PET.

Read full original descriptionShow less

The main questions this study aims to answer are:

* How do small but important brain regions (like the locus coeruleus, substantia nigra, and thalamic nuclei) change in healthy aging? * What early brain changes occur in neurodegenerative and psychotic disorders, and can they help improve early diagnosis?

Participants will:

* 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). * Complete cognitive and clinical assessments related to memory, mood, and motor or psychiatric symptoms, depending on their group.

This 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.

The 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.

The 5 groups in the trial

Healthy controlsOther group
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.
Treatment: UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-PE2I, UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1, UHR PET/CT scan of the brain with ¹⁸F-MK6240, and 3T MRI imaging of the brain
Patient with aMCIOther group
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.
Treatment: UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-MK6240, and 3T MRI imaging of the brain
Patients with ALS/ALS-FTDOther group
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.
Treatment: UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1, and 3T MRI imaging of the brain
Patients with movement disordersOther group
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.
Treatment: UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1, and 3T MRI imaging of the brain
Patients with psychotic disordersOther group
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.
Treatment: UHR PET/CT scan of the brain with ¹⁸F-FDG and 3T MRI imaging of the brain