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Synaptic Density and Progression of Huntington's Disease.

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ClinicalTrials.gov Identifier: NCT04701580
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.


Condition or disease Intervention/treatment Phase
Huntington Disease Diagnostic Test: 11C-UCB-J PET-CT Diagnostic Test: 18F-FDG PET-MR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Longitudinal study design (2 years follow up) where results of SV2A PET/CT, FDG PET/MR and clinical rating scales are compared between HD patients and healthy controls.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal Measurement of Synaptic Density to Monitor Progression of Huntington's Disease.
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HD patients
At baseline and 2-year follow-up
Diagnostic Test: 11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

Diagnostic Test: 18F-FDG PET-MR
Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.

Active Comparator: Healthy controls
At baseline and 2-year follow-up
Diagnostic Test: 11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

Diagnostic Test: 18F-FDG PET-MR
Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.




Primary Outcome Measures :
  1. Baseline differences in synaptic density. [ Time Frame: Data analysis wel be done when all subjects have undergone the baseline evaluation. ]
    Baseline differences (%) in (regional) synaptic density between patients and controls.

  2. Baseline correlations between clinical scores and regional synaptic density. [ Time Frame: Data analysis wel be done when all subjects have undergone the baseline evaluation. ]
    Correlations between clinical scores and regional synaptic density in the patient group at baseline.

  3. Differences in the rate of decline of synaptic density. [ Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. ]
    Differences (%) in the rate of decline of synaptic density between patients and controls.

  4. Correlations between progression of the clinical scores and decline of synaptic density. [ Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. ]
    Correlations between progression of the clinical scores and decline of synaptic density in the patient group, after longitudinal follow up of 2 years.


Secondary Outcome Measures :
  1. Baseline differences in cerebral glucose metabolism. [ Time Frame: Data analysis wel be done when all subjects have undergone the baseline evaluation. ]
    Baseline differences (%) in (regional) glucose metabolism between patients and controls.

  2. Baseline correlations between clinical scores and cerebral glucose metabolism. [ Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. ]
    Correlations between clinical scores and cerebral glucose metabolism in the patient group at baseline.

  3. Differences in the rate of decline of cerebral glucose metabolism. [ Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. ]
    Differences (%) in the rate of decline in cerebral glucose metabolism between patients and controls.

  4. Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years. [ Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. ]
    Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701580


Contacts
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Contact: Wim Vandenberghe, MD, PhD +3216344280 wim.vandenberghe@uzleuven.be
Contact: Aline Delva, MD +3216345771 aline.delva@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Aline Delva, Dr.    +3216345771    aline.delva@uzleuven.be   
Sub-Investigator: Aline Delva, Dr.         
Principal Investigator: Wim Vandenberghe, Prof. Dr.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Wim Vandenberghe, MD, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04701580    
Other Study ID Numbers: s61478
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Needs to be decided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Huntington Disease
PET
11C-UCB-J
18F-FDG
SV2A
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action