Status:
COMPLETED
Preparing for Prevention of Huntington's Disease (PREVENT-HD)
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Huntington Disease
Eligibility:
All Genders
18-80 years
Brief Summary
This is a prospective investigation which aims to address key challenges to the design of clinical trials to prevent the onset of Huntington's disease (HD). The project will provide necessary psychome...
Detailed Description
This is a prospective investigation which aims to address key challenges to the design of clinical trials to prevent the onset of Huntington's disease (HD). The project will provide necessary psychome...
Eligibility Criteria
Inclusion
- Inclusion Criteria for HD Participants:
- Estimated at low or high probability of motor diagnosis based on the multivariate risk score (MRS)
- Willing to commit to two in-person assessment visits (baseline and 2-year follow-up) and remote assessments as needed
- No active comorbidities (i.e. receiving stable treatment)
- All medications will be allowed although the protocol will mandate documentation of medications and analyses will particularly assess potential impact of medications on outcomes (i.e., sedation of abnormal movements)
- If previously measured, CAG results must be 36 or above (previous CAG is not a requirement, but this threshold will be upheld for those participants who have their CAG scores and/or have them in their medical record).
- Inclusion Criteria for Healthy Controls (HC):
- Willing to commit to two in-person assessment visits (baseline and 2-year follow-up) and remote assessments as needed
- In generally good health
- IQ \> 70
- Able to undergo an MRI scan
- Exclusion Criteria (for all Participants):
- Evidence of unstable medical or psychiatric illness (including substance abuse)
- History of severe learning disability, mental retardation, or other central nervous system (CNS) disease or event (e.g., seizures, head trauma, additional neurological diagnoses)
- Treatment with phenothiazine-derivative antiemetic medications such as prochlorperazine, metoclopramide, promethazine and Inapsine greater than 3 times per month
- History of serious alcohol or drug abuse within the past year
- Unable (determined by patient's prescribing doctor) to not take tryptophan, leucine, niacin or niacinamide-containing dietary supplements, anti-inflammatory medications, anti-coagulants (such as warfarin and heparin) or anti-platelets (such as aspirin) in the past 14 days to assure safety during lumbar puncture
- Unable to fast (no food or drink, only water) overnight before the lumbar puncture
Exclusion
Key Trial Info
Start Date :
September 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT04818060
Start Date
September 13 2021
End Date
January 31 2025
Last Update
March 18 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705