Studies

Interventional Recruiting

NCT07509125 on ClinicalTrials.gov

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

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

  • Sponsor: Universitair Ziekenhuis Leuven
  • Enrollment: 300 (Estimated)
  • Study start: 2026-02-13 (Actual)
  • Primary completion: 2029-09-01 (Estimated)
  • Study completion: 2029-09-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Depending on the work package, patients under 50 years old will receive a combination of 2 different tracers, and those above 50 years old an optional additional 3th tracer
  • Masking: None
  • PrimaryPurpose: Diagnostic

Brief 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.

Conditions

  • Alzheimer Dementia (AD)
  • ALS - Amyotrophic Lateral Sclerosis
  • Parkinson s Disease
  • REM Sleep Behavior Disorder (iRBD)
  • PSP - Progressive Supranuclear Palsy
  • MSA - Multiple System Atrophy
  • Dementia With Lewy Bodies (DLB)
  • ALS With Frontotemporal Dementia (ALS/FTD)
  • Adult Onset Psychotic Disorder
  • Very Late Onset Psychotic Disorder

Intervention / Treatment

  • Other: UHR PET/CT scan of the brain with ¹⁸F-FDG
  • Other: UHR PET/CT scan of the brain with ¹⁸F-PE2I
  • Other: UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1
  • Other: UHR PET/CT scan of the brain with ¹⁸F-MK6240
  • Other: 3T MRI imaging of the brain

Primary Outcome Measures

  • Volume distribution (mL/cm³) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240 (Through study completion, an average of 4 year)
    To evaluate the regional binding patterns in small brain nuclei using four PET tracers (18F-FDG, 18F-PE2I, 18F-SynVest-1, 18F-MK6240) in different subject groups (healthy controls and disease cohorts). Quantitative outcome metrics will include distribution volumes with and without partial volume correction (PVC).
  • Standardized uptake value ratios (SUVR) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240 (Through study completion, an average of 4 year)
    To evaluate the regional binding patterns in small brain nuclei using four PET tracers (18F-FDG, 18F-PE2I, 18F-SynVest-1, 18F-MK6240) in different subject groups (healthy controls and disease cohorts). Quantitative outcome metrics will include standardized uptake value ratios (SUVR) with and without partial volume correction (PVC).

Countries

Belgium

Locations and Investigators