Longitudinal SV2A and MRI in Premanifest HD

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Huntington Disease

Treatments: Diagnostic Test: Volumetric MRI; Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET

Study type: Interventional

Funder types: Other

Identifiers

NCT06626412

S69109

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Premanifest HD

Experimental group

Description:

At baseline and 2-year follow-up

Treatment:

Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET

Diagnostic Test: Volumetric MRI

Healthy controls

Active Comparator group

Description:

At baseline and 2-year follow-up

Treatment:

Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET

Diagnostic Test: Volumetric MRI