Status:
UNKNOWN
Natural History Study in Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD
Lead Sponsor:
CHDI Foundation, Inc.
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Huntington Disease
Eligibility:
All Genders
18-63 years
Brief Summary
SHIELD HD is an international, multisite, prospective, longitudinal cohort natural history study to assess the natural history of HD and its biomarkers that are associated with modulation of the numbe...
Detailed Description
The rationale for this study is to obtain longitudinal information related to Somatic Instability and DNA damage response genes in HDGECs at various stages of the disease. Established assessments of d...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Patients who meet all of the following criteria will be eligible to participate in the study:
- Capacity to comprehend the study objectives and procedures
- Documentation of genetically confirmed disease by direct DNA testing, defined as a CAG repeat length ≥39 in the HTT gene
- Ability to undergo and tolerate MRI scans
- Ability to tolerate blood draws and lumbar punctures
- Key Exclusion Criteria
- Patients who meet any of the following criteria will be excluded from participation in the study:
- Any conditions, including severe chorea and dementia, that would prevent either writing or performing pen and paper, tablet, or computer based tasks as determined by the Investigator
- Treatment with an investigational drug within 30 days prior to screening or within 5 half lives of the investigational drug, whichever is longer
- History of gene therapy or cell transplantation or any other experimental brain surgery
Exclusion
Key Trial Info
Start Date :
May 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04406636
Start Date
May 19 2020
End Date
April 1 2023
Last Update
September 23 2022
Active Locations (10)
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1
University of California, San Diego (UCSD)
San Diego, California, United States, 920161
2
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States, 80113
3
Beth Israel Deaconess
Boston, Massachusetts, United States, 02215
4
Columbia University
New York, New York, United States, 10032