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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premanifest HD | Experimental | At baseline and 2-year follow-up |
|
| Healthy controls | Active Comparator | At baseline and 2-year follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: 18F-SynVesT-1 PET | Diagnostic Test | Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline differences in synaptic density. | Baseline differences in (regional) synaptic density between premanifest HD and controls. | Data analysis will be done when all subjects have undergone the baseline evaluation. |
| Baseline differences in brain volume. | Baseline differences in (regional) brain volume between premanifest HD and controls. | Data analysis will be done when all subjects have undergone the baseline evaluation. |
| Differences in the rate of decline of synaptic density. | Differences in the rate of decline of (regional) synaptic density between patients and controls; Sensitivity to change for synaptic density. | Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation. |
| Differences in the rate of decline of volumetric MRI. | Differences in the rate of decline of (regional) brain volumes between patients and controls; Sensitivity to change for (regional) brain volumes. | Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline correlations between clinical scores and regional synaptic density or brain volume. | Correlations between clinical scores and regional synaptic density or regional volume loss in the patient group at baseline. | Data analysis will be done when all subjects have undergone the baseline evaluation. |
| Correlations between progression of the clinical scores and decline of synaptic density or brain volume. |
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Inclusion Criteria:
Age 20-75 years inclusive.
Capacity to understand the informed consent form.
HD mutation carriers:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Volumetric MRI | Diagnostic Test | Magnetic resonance imaging of brain volume. |
|
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. |
| Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation. |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |