Status:
RECRUITING
Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
CHDI Foundation, Inc.
Conditions:
Huntington Disease
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
Positron Emission Tomography (PET) is a functional imaging technique, which enables in vivo visualization of biological molecules expressed in human tissues. Brain PET is most powerful to study a vast...
Eligibility Criteria
Inclusion
- Healthy controls (n = 10-20)
- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.
- No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment.
- In subjects \< 60 years of age, an unremarkable structural MRI scan as assessed by expert radiologist. In subjects \>= 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \< 2 on the Age-Related White Matter changes scale are acceptable.
- HD-ISS stage 3 HD mutation carriers (n = 10)
- HTT CAG repeat expansion 40 - 50
- stage 3 as determined by the HD-ISS staging criteria
- UHDRS TFC \>/= 10
- HD-ISS stage 2 HD mutation carriers (n = 10)
- HTT CAG repeat expansion 40 - 50
- stage 2 as determined by the HD-ISS staging criteria
- PIN score 0.47 - 1.84
Exclusion
- Neuropsychiatric diseases; for HD mutation carriers any neuropsychiatric diseases other than HD
- Major internal medical diseases
- White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
- History of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug use
- Contraindications for MR
- Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for 30 minutes inside the scanner.
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.
- Subject does not understand the study procedures or does not have a guardian who understands the study procedures.
- Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
- Subject is on anticoagulant therapy.
- Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.
- Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion.
- Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05360082
Start Date
November 18 2024
End Date
December 1 2026
Last Update
July 30 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000