RecruitingNot ApplicableNCT06626412

Longitudinal SV2A and MRI in Premanifest HD

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

35 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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.

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Interventions

DIAGNOSTIC_TESTDiagnostic Test: 18F-SynVesT-1 PET

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

DIAGNOSTIC_TESTVolumetric MRI

Magnetic resonance imaging of brain volume.


Locations(1)

University Hospitals Leuven

Leuven, Belgium

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NCT06626412


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