Comparing two PET imaging techniques in Huntington Disease

Direct Quantitative Comparison Between [11C]UCB-J and [18F]SynVest-1 PET as Markers for Synaptic Density in Huntington's Disease.

This study is testing two different PET imaging techniques to see which one better shows changes in the brain of people with Huntington Disease and how those changes relate to movement problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven)
• Trial ID: NCT05360082 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the effectiveness of two positron emission tomography (PET) imaging techniques, [11C]UCB-J and [18F]SynVest-1, in assessing synaptic density in patients with Huntington Disease (HD). The study will involve healthy controls and HD mutation carriers, focusing on the correlation between synaptic loss and motor impairment. By utilizing advanced imaging methods, the research seeks to establish a reliable biomarker for evaluating synaptic integrity in the human brain affected by HD.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals and HD mutation carriers with specific genetic criteria and no significant neurological disorders.

Not a fit: Patients with significant neurological or psychiatric disorders unrelated to Huntington Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new biomarker for monitoring disease progression and treatment response in Huntington Disease patients.

How similar studies have performed: Previous studies have shown promising results using similar PET imaging techniques in neurological disorders, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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
3. 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 Criteria:

* 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.

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Principal investigator: Koen Van Laere, MD, PhD, DSc — UZ/KU Leuven
• Study coordinator: Koen Van Laere, MD, PhD, DSc

Conditions Huntington Disease; PET; SV2A; Huntington disease; synaptic density