ClinicalTrials.gov record NCT07509125

Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 90 years old
SexAll
LocationBelgium
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This diagnostic study uses an ultra‑high‑resolution PET/CT scanner (NeuroEXPLORER) together with 3T MRI to image small brain and spinal cord structures in healthy volunteers and people with a range of neurodegenerative and psychotic disorders. Participants receive PET scans with one or more tracers (¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1, ¹⁸F-MK6240), MRI, and clinical/cognitive assessments. No therapeutic treatment is given; groups are studied in parallel.

What it is studying. The study tests whether ultra‑high‑resolution PET combined with 3T MRI can detect small-scale changes in specific brain and spinal cord regions across healthy aging and in several disorders, and whether those imaging measures relate to cognitive, motor, or psychiatric symptoms.

What the researchers hope to learn. To produce detailed imaging maps of small brain nuclei in healthy aging and in disease, and to identify imaging markers that correlate with cognitive, motor, and clinical measures across different disorders.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • 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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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).

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have ultra-high-resolution PET scans of the brain using one or more tracers (¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and/or ¹⁸F-MK6240) and a 3T MRI (including neuromelanin-sensitive and diffusion-weighted imaging). They will complete cognitive and clinical assessments for memory, mood, motor, or psychiatric symptoms and give blood samples (volunteers over 50 are asked to provide a p-tau217 blood sample). Some participants may undergo arterial blood sampling that requires placement of an arterial catheter (local anaesthesia with lidocaine); a pregnancy test (hCG) may be done if pregnancy is possible. No therapeutic treatment is given as part of the study; the exact scans and samples a person receives depend on the study arm they are assigned to.

How the study is structured. Interventional, diagnostic study with non-randomized, parallel groups (healthy controls and several patient groups). Participants undergo one or more UHR PET/CT scans using specified radiotracers and a 3T MRI scan. There is no masking and no therapeutic intervention; imaging and clinical assessments are compared across groups. Key imaging outcomes are measured through study completion (timeframe noted in the registry).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on progressive supranuclear palsy

This trial is also listed on this site under multiple system atrophy.

Clinical trials45 trials listed for progressive supranuclear palsyEvery trial the registry lists for progressive supranuclear palsy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in progressive supranuclear palsy researchLatest monthly update: September 2026. Includes: PSP vs Parkinsons. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 13, 2026
Primary completion
September 2029 (estimated)
Study completion
September 2029 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
Apr 3, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Universitaire Ziekenhuizen KU Leuven

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
principal investigator
The doctor or scientist responsible for running the study at a site or overall.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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