Synaptic Density and Progression of Huntington's Disease.

Huntington Disease Clinical Trial

Official title:

Longitudinal Measurement of Synaptic Density to Monitor Progression of Huntington's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701580
• Other study ID #: s61478
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: October 5, 2022

Study information

• Verified date: November 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Diagnostic Test:
• 11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
• 18F-FDG PET-MR
Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline differences in synaptic density.	Baseline differences (%) in (regional) synaptic density between patients and controls.	Data analysis wel be done when all subjects have undergone the baseline evaluation.
Primary	Baseline correlations between clinical scores and regional synaptic density.	Correlations between clinical scores and regional synaptic density in the patient group at baseline.	Data analysis wel be done when all subjects have undergone the baseline evaluation.
Primary	Differences in the rate of decline of synaptic density.	Differences (%) in the rate of decline of synaptic density between patients and controls.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Primary	Correlations between progression of the clinical scores and decline of synaptic density.	Correlations between progression of the clinical scores and decline of synaptic density in the patient group, after longitudinal follow up of 2 years.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary	Baseline differences in cerebral glucose metabolism.	Baseline differences (%) in (regional) glucose metabolism between patients and controls.	Data analysis wel be done when all subjects have undergone the baseline evaluation.
Secondary	Baseline correlations between clinical scores and cerebral glucose metabolism.	Correlations between clinical scores and cerebral glucose metabolism in the patient group at baseline.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary	Differences in the rate of decline of cerebral glucose metabolism.	Differences (%) in the rate of decline in cerebral glucose metabolism between patients and controls.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary	Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.	Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.