NCT07509125

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	UHR PET/CT scan of the brain with ¹⁸F-FDG	Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-FDG radiotracer to assess glucose metabolism
OTHER	UHR PET/CT scan of the brain with ¹⁸F-PE2I	Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-PE2I radiotracer to assess dopaminergic activity
OTHER	UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1	Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-SynVesT-1 radiotracer to assess synaptic density
OTHER	UHR PET/CT scan of the brain with ¹⁸F-MK6240	Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-MK6240 radiotracer to assess neurofibrillary tangles
OTHER	3T MRI imaging of the brain	All participants will undergo 3T MRI, including T1- and FLAIR-weighted sequences for anatomical reference and white matter pathology, neuromelanin-sensitive imaging to assess SN and LC integrity, and multi-shell diffusion-weighted imaging (DWI) for white matter tractography.

Timeline

• Start date: 2026-02-13
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Belgium