Synaptic Damage and Its Clinical Correlates in People With Early Huntington Disease: A PET Study.
Aline Delva, Laura Michiels, Michel Koole...
https://pubmed.ncbi.nlm.nih.gov/34663644Actively Recruiting
Phase Not Applicable
Age: 20Years - 75Years
All Genders
Healthy Volunteers
ID05360082
Direct Quantitative Comparison Between [11C]UCB-J and [18F]SynVest-1 PET as Markers for Synaptic Density in Huntington's Disease
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-07-30
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
C
CHDI Foundation, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Positron Emission Tomography (PET) is a technique that allows visualization of biological molecules in the brain, which is useful for studying neurological and psychiatric disorders. This research focuses on Huntington's disease (HD) and evaluates two PET radioligands, [11C]UCB-J and [18F]SynVest-1, that target synaptic density. Previous studies showed loss of synaptic binding in HD patients, and this trial aims to compare the performance of these two tracers in humans to validate their use as biomarkers for synaptic integrity and disease progression. Participants will undergo PET imaging with both [11C]UCB-J and [18F]SynVest-1 radioligands to directly compare their binding properties. The study involves two cohorts of HD patients at different disease stages (stage 2 and stage 3) and age- and sex-matched healthy controls. The study will analyze data from cohort 1 before proceeding with cohort 2, ensuring a thorough evaluation of tracer performance. This head-to-head comparison will help determine if [18F]SynVest-1 can provide similar data quality to [11C]UCB-J. During the study, participants will receive PET scans and undergo clinical and neuropsychological assessments to evaluate synaptic density and motor impairment. The main outcome measure is the comparison of volume of distribution (Vt) between the two tracers in HD patients and controls. Additional analyses include comparing variability and simplified measures of tracer binding. The study will monitor participants for safety and compliance, with participation expected to last through completion of imaging and assessments for both cohorts.
CONDITIONS
Brief Title
Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Who Can Participate
Age: 20Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy controls judged to be in good health by investigator
- No history or evidence of major neurological, internal, or psychiatric disorders
- For participants under 60, an unremarkable structural MRI scan; for those 60 or older, acceptable white matter lesion score less than 2
- HD mutation carriers with CAG repeat expansion 40 to 50
- Stage 3 HD patients with UHDRS TFC score of 10 or higher
- Stage 2 HD patients with PIN score between 0.47 and 1.84
You will not qualify if you...
- Presence of neuropsychiatric diseases other than Huntington's disease for mutation carriers
- Major internal medical diseases
- White matter lesion load Fazekas score 2 or higher or other significant MRI abnormalities
- History or current alcohol abuse exceeding 15 units per week or drug use
- Contraindications for MRI
- Claustrophobia or inability to tolerate PET-MRI scanning or lie still for 30 minutes
- Unwillingness to avoid strenuous physical activity during study period
- Inability to understand study procedures or lack of guardian who understands them
- Unwillingness or inability to perform all study procedures
- Use of anticoagulant therapy
- Pregnancy or breastfeeding
- Women of childbearing potential not agreeing to contraception during and for 6 months after study
- Men with partners of childbearing potential not agreeing to use condoms and partner contraception as required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo PET imaging using [11C]UCB-J and [18F]SynVest-1 to assess synaptic density.
2 imaging visits (in-person)
Long-term Monitoring
Duration - Up to 6 months
Participants are observed following imaging to assess outcomes and safety.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
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Research Team
K
Koen Van Laere, MD, PhD, DSc
W
Wim Vandenberghe, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Published Research Related To This Trial
Imaging synaptic density in the living human brain.
Sjoerd J Finnema, Nabeel B Nabulsi, Tore Eid...
https://pubmed.ncbi.nlm.nih.gov/27440727First-in-Human Evaluation of 18F-SynVesT-1, a Radioligand for PET Imaging of Synaptic Vesicle Glycoprotein 2A.
Mika Naganawa, Songye Li, Nabeel Nabulsi...
https://pubmed.ncbi.nlm.nih.gov/32859701