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Active, Not Recruiting

NCT Number: NCT06626412

Longitudinal SV2A PET and MRI in Premanifest HD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic Test: 18F-SynVesT-1 PET

Diagnostic Test

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

Volumetric MRI

Diagnostic Test

Magnetic resonance imaging of brain volume.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Longitudinal Imaging of Striatal Synaptic Density and Volume in People With Premanifest Huntington's Disease.

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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