Health Trials

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

ConditionsAlzheimer Dementia (AD)ALS - Amyotrophic Lateral SclerosisParkinson s DiseaseREM Sleep Behavior Disorder (iRBD)PSP - Progressive Supranuclear PalsyMSA - Multiple System AtrophyDementia With Lewy Bodies (DLB)ALS With Frontotemporal Dementia (ALS/FTD)Adult Onset Psychotic DisorderVery Late Onset Psychotic Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov