Synaptic Density and Progression of Huntington's Disease.

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Huntington Disease

Treatments: Diagnostic Test: 11C-UCB-J PET-CT; Diagnostic Test: 18F-FDG PET-MR

Study type: Interventional

Funder types: Other

Identifiers

NCT04701580

s61478

Details and patient eligibility

About

AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with HD.

DESIGN: The investigators will include 20 HD mutations carriers and 15 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FDG PET-MR at baseline and after 2 years.

Enrollment: 33 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 20-75 years.

• Capacity to understand the informed consent form.

• For HD group: CAG repeat expansion in HTT ≥ 40.

• Premanifest HD mutation carriers:

  * No clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4.

• Early manifest HD patients:

  • Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4.
  • UHDRS-TFC score 7 or higher (Shoulson-Fahn stage 1 and 2).

Exclusion criteria

• neuropsychiatric diseases other than HD
• 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 >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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33 participants in 2 patient groups

HD patients

Experimental group

Description:

At baseline and 2-year follow-up

Treatment:

Diagnostic Test: 11C-UCB-J PET-CT

Diagnostic Test: 18F-FDG PET-MR

Healthy controls

Active Comparator group

Description:

At baseline and 2-year follow-up

Treatment:

Diagnostic Test: 11C-UCB-J PET-CT

Diagnostic Test: 18F-FDG PET-MR