Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders (NCT07509125) | Clinical Trial Compass
RecruitingNot Applicable
Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders
Belgium300 participantsStarted 2026-02-13
Plain-language summary
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.
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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (3…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Volume distribution (mL/cm³) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240
Timeframe: Through study completion, an average of 4 year
2
Standardized uptake value ratios (SUVR) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240
Timeframe: Through study completion, an average of 4 year