NCT06626412

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2024Dec 2028

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

October 1, 2024

Last Update Submit

April 28, 2026

Conditions

Huntington Disease

Keywords

PETMRISV2Asynaptic density18F-SynVesT-1

Outcome Measures

Primary Outcomes (4)

  • Baseline differences in synaptic density.

    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.

    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.

    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.

    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 Outcomes (2)

  • Baseline correlations between clinical scores and regional synaptic density or brain volume.

    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.

    Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.

Study Arms (2)

Premanifest HD

EXPERIMENTAL

At baseline and 2-year follow-up

Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PETDiagnostic Test: Volumetric MRI

Healthy controls

ACTIVE COMPARATOR

At baseline and 2-year follow-up

Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PETDiagnostic Test: Volumetric MRI

Interventions

Diagnostic Test: 18F-SynVesT-1 PETDIAGNOSTIC_TEST

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.

Healthy controlsPremanifest HD
Volumetric MRIDIAGNOSTIC_TEST

Magnetic resonance imaging of brain volume.

Healthy controlsPremanifest HD

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

December 4, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

BE(1)