UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
NCT Number: NCT07509125
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-FDG radiotracer to assess glucose metabolism
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-PE2I radiotracer to assess dopaminergic activity
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-SynVesT-1 radiotracer to assess synaptic density
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-MK6240 radiotracer to assess neurofibrillary tangles
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.
Time frame: 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).
Time frame: 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).
Time frame: Through study completion, an average of 4 year
Quantitative PET measures (SUVR from ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVest-1, and ¹⁸F-MK6240) will be correlated with cognitive performance across disease cohorts.
Cognitive outcomes will be assessed using standardized neuropsychological tests covering global cognition, memory, language, executive function, and attention.
Examples include the Montreal Cognitive Assessment (MoCA) (0-30, a higher score indicating a better outcome), Boston Naming Test (BNT) (0-60, a higher score indicating a better outcome) and Raven's Coloured Progressive Matrices (RCPM) (0-24, a higher score indicating a better outcome)
Time frame: Through study completion, an average of 4 year
Quantitative PET measures (SUVR from ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVest-1, and ¹⁸F-MK6240) will be correlated with motor and functional outcome measures, including performance across disease cohorts. Cognitive outcomes will be assessed using standardized clinical rating scales such as the MDS-UPDRS (all items scored between 0-4, with a higher score indicative of a higher symptom severity)
Contact information is provided by the study sponsor or research team.
Francine Reniers
CONTACT
Koen Van Laere, Prof. Dr.
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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