Longitudinal SV2A PET and MRI in Premanifest HD

April 28, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy controls
At baseline and 2-year follow-up
Diagnostic test: Diagnostic Test: 18F-SynVesT-1 PET
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.
Diagnostic test: Volumetric MRI
Magnetic resonance imaging of brain volume.
Experimental: Premanifest HD
At baseline and 2-year follow-up
Diagnostic test: Diagnostic Test: 18F-SynVesT-1 PET
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.
Diagnostic test: Volumetric MRI
Magnetic resonance imaging of brain volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data analysis will be done when all subjects have undergone the baseline evaluation.
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.
Data analysis will be done when all subjects have undergone the baseline evaluation.
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.
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.
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.
Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 clinical scores and regional synaptic density or regional volume loss in the patient group at baseline.
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.
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.
Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S69109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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