Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT07509125

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-03

300

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 90 years old
  • Healthy controls with no major neurological, internal, or psychiatric disorders
  • Montreal Cognitive Assessment (MoCA) score of 26 or higher for healthy subjects
  • Normal or acceptable MRI findings based on age and clinical assessment
  • Willingness to provide blood sample for p-tau217 if older than 50 years
  • Clinical diagnosis of biomarker-proven prodromal Alzheimer's disease for dementia group
  • Diagnosis meeting El Escorial and Awaji-Shima criteria for ALS spectrum
  • Ability to understand study information and provide informed consent
  • Clinically established Parkinson's disease with abnormal 18F-PE2I PET and no cognitive impairment
  • Clinically established or probable multiple system atrophy with abnormal 18F-PE2I PET
  • Clinically established probable progressive supranuclear palsy with abnormal 18F-PE2I PET
  • Probable dementia with Lewy bodies with cognitive impairment and abnormal 18F-PE2I PET
  • Polysomnography-confirmed idiopathic REM sleep behavior disorder with no cognitive impairment
  • DSM 5 diagnosis of non-affective schizophrenia spectrum psychotic disorder with age criteria
Not Eligible

You will not qualify if you...

  • History of major internal, psychiatric, or neurological diseases that interfere with the study
  • Current or past use of illicit drugs or history of drug or alcohol abuse
  • Chronic use of medications with central nervous system effects unless prescribed for illness
  • Exposure to ionizing radiation >1 mSv from other studies within the last 12 months
  • Contraindications for MRI scanning
  • Claustrophobia or inability to lie still for at least 60 minutes during scanning
  • Hypersensitivity to lidocaine, abnormal Allen test, or on anti-coagulant therapy for arterial sampling
  • Inability to understand study procedures
  • Unwillingness or inability to complete all study procedures
  • Potential pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

Loading map...

Research Team

K

Koen Van Laere, Prof. Dr.

CONTACT

F

Francine Reniers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

5

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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