Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2024-12-04
2028-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Premanifest HD
At baseline and 2-year follow-up
Diagnostic Test: 18F-SynVesT-1 PET
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.
Volumetric MRI
Magnetic resonance imaging of brain volume.
Healthy controls
At baseline and 2-year follow-up
Diagnostic Test: 18F-SynVesT-1 PET
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.
Volumetric MRI
Magnetic resonance imaging of brain volume.
Interventions
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Diagnostic Test: 18F-SynVesT-1 PET
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.
Volumetric MRI
Magnetic resonance imaging of brain volume.
Eligibility Criteria
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Inclusion Criteria
* Capacity to understand the informed consent form.
* HD mutation carriers:
* HTT (CAG)n ≥ 40
* HD-ISS \< 2
* CAP100 score \> 70
Exclusion Criteria
* 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.
20 Years
75 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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Facility Contacts
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Wim Vandenberghe, MD, PhD
Role: primary
Other Identifiers
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S69109
Identifier Type: -
Identifier Source: org_study_id