Longitudinal SV2A PET and MRI in Premanifest HD (NCT06626412) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Longitudinal SV2A PET and MRI in Premanifest HD
Belgium40 participantsStarted 2024-12-04
Plain-language summary
AIM: to compare the sensitivity of SV2A PET and volumetric MRI to detect longitudinal striatal changes in premanifest HD.
DESIGN: The investigators will include late premanifest HD mutations carriers and matched healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 18F-SynVesT-1 PET and volumetric MRI at baseline and after 2 years.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 20-75 years inclusive.
* Capacity to understand the informed consent form.
* HD mutation carriers:
* HTT (CAG)n ≥ 40
* HD-ISS \< 2
* CAP100 score \> 70
Exclusion Criteria:
* neuropsychiatric diseases (other than HD for HD mutation carriers)
* 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 abuse
* contraindications for MR
* pregnancy
* previous participation in other research studies involving ionizing radiation with more than 1 mSv in the previous 12 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline differences in synaptic density.
Timeframe: Data analysis will be done when all subjects have undergone the baseline evaluation.
2
Baseline differences in brain volume.
Timeframe: Data analysis will be done when all subjects have undergone the baseline evaluation.
3
Differences in the rate of decline of synaptic density.
Timeframe: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
4
Differences in the rate of decline of volumetric MRI.
Timeframe: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.