Longitudinal SV2A PET and MRI in Premanifest HD

N/AActive Not RecruitingNCT06626412

Universitaire Ziekenhuizen KU Leuven40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Huntington Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Baseline differences in synaptic density.

Baseline differences in (regional) synaptic density between premanifest HD and controls.

Time frame: 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.

Time frame: 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.

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 volumetric MRI.

Differences in the rate of decline of (regional) brain volumes between patients and controls; Sensitivity to change for (regional) brain volumes.

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

Secondary Outcomes

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.

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.

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 from ClinicalTrials.gov

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