Longitudinal SV2A and MRI in Premanifest HD

Not Applicable

Recruiting

• Conditions: Huntington Disease
• Interventions: Diagnostic Test: Volumetric MRI

• Registration Number: NCT06626412
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Status Verified: 2024-12
• Study Start: 2024-12-04
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Premanifest HD	Volumetric MRI	At baseline and 2-year follow-up
Healthy controls	Volumetric MRI	At baseline and 2-year follow-up

Primary Outcome Measures

Name	Time	Method
Baseline differences in synaptic density.	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.	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.	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.	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.

Secondary Outcome Measures

Name	Time	Method
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 clinical scores and regional synaptic density or regional volume loss in the patient group at baseline.
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.	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.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium