Huntington DiseaseNCT06626412
Longitudinal SV2A PET and MRI in Premanifest HD
A study testing Diagnostic Test: 18F-SynVesT-1 PET and Volumetric MRI in people with Huntington Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Diagnostic Test: 18F-SynVesT-1 PET and Volumetric MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Dec 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Imaging of Striatal Synaptic Density and Volume in People With Premanifest Huntington's Disease.
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.
- Conditions
- Huntington Disease
- Being tested
- Diagnostic Test: 18F-SynVesT-1 PET, Volumetric MRI
- Keywords
- PET, MRI, SV2A, synaptic density, 18F-SynVesT-1
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: 18F-SynVesT-1 PETDiagnostic test
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.
Volumetric MRIDiagnostic test
Magnetic resonance imaging of brain volume.
| Study group | Role | What they receive |
|---|---|---|
| Premanifest HD | Experimental | At baseline and 2-year follow-up Receives: Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET; Diagnostic Test: Volumetric MRI |
| Healthy controls | Active comparator | At baseline and 2-year follow-up Receives: Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET; Diagnostic Test: Volumetric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline differences in synaptic density.
Baseline differences in (regional) synaptic density between premanifest HD and controls.
Measured: Data analysis will be done when all subjects have undergone the baseline evaluation.
Baseline differences in brain volume.
Baseline differences in (regional) brain volume between premanifest HD and controls.
Measured: Data analysis will be done when all subjects have undergone the baseline evaluation.
Differences in the rate of decline of synaptic density.
Differences in the rate of decline of (regional) synaptic density between patients and controls; Sensitivity to change for synaptic density.
Measured: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of volumetric MRI.
Differences in the rate of decline of (regional) brain volumes between patients and controls; Sensitivity to change for (regional) brain volumes.
Measured: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary outcomes (2)
Baseline correlations between clinical scores and regional synaptic density or brain volume.
Correlations between clinical scores and regional synaptic density or regional volume loss in the patient group at baseline.
Measured: Data analysis will be done when all subjects have undergone the baseline evaluation.
Correlations between progression of the clinical scores and decline of synaptic density or brain volume.
Correlations between progression of the clinical scores and decline of synaptic density or regional volume loss in the patient group, after longitudinal follow up of 2 years.
Measured: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start4 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626412
- Sponsor's protocol ID
- S69109
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Imaging of Striatal Synaptic Density and Volume in People With Premanifest Huntington's Disease.
- ClinicalTrials.gov ID
- NCT06626412
- Acronym / sponsor ID
- S69109
- Conditions
- Huntington Disease
- Keywords
- PET, MRI, SV2A, synaptic density, 18F-SynVesT-1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premanifest HD | Experimental | Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET, Diagnostic Test: Volumetric MRIAt baseline and 2-year follow-up |
| Healthy controls | Active comparator | Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET, Diagnostic Test: Volumetric MRIAt baseline and 2-year follow-up |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 20-75 years inclusive.
- Capacity to understand the informed consent form.
- HD mutation carriers:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: 18F-SynVesT-1 PETPositron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1. | Diagnostic test | Healthy controls, Premanifest HD |
| Volumetric MRIMagnetic resonance imaging of brain volume. | Diagnostic test | Healthy controls, Premanifest HD |
Primary outcome
Baseline differences in synaptic density.
Time frame: Data analysis will be done when all subjects have undergone the baseline evaluation.
Baseline differences in (regional) synaptic density between premanifest HD and controls.
Baseline differences in brain volume.
Time frame: Data analysis will be done when all subjects have undergone the baseline evaluation.
Baseline differences in (regional) brain volume between premanifest HD and controls.
Differences in the rate of decline of synaptic density.
Time frame: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of (regional) synaptic density between patients and controls; Sensitivity to change for synaptic density.
Differences in the rate of decline of volumetric MRI.
Time frame: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of (regional) brain volumes between patients and controls; Sensitivity to change for (regional) brain volumes.
2 secondary outcomes
Baseline correlations between clinical scores and regional synaptic density or brain volume.
Time frame: Data analysis will be done when all subjects have undergone the baseline evaluation.
Correlations between progression of the clinical scores and decline of synaptic density or brain volume.
Time frame: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: 18F-SynVesT-1 PET and Volumetric MRI in people with Huntington Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline differences in synaptic density. (time frame: Data analysis will be done when all subjects have undergone the baseline evaluation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.