NCT04818060Completed
Preparing for Prevention of Huntington's Disease (PREVENT-HD)
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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 psychometric data for clinical outcome assessments (COAs) and biomarkers (BMs) in the cerebral spinal fluid (CSF) to address questions of central importance to the success of these measures for premanifest clinical trials. Of the 258 participants: 52 will be low risk of motor diagnosis, 102 high risk of motor diagnosis, 52 with diagnosed HD (stages I or II), and 52 healthy controls. Participants can expect to be in the study for up to 2 years.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 258 (actual)
- First submitted
- 15 Mar 2021
- Start date
- Sept 2021
- Primary completion date
- Jan 2025
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Huntington's disease
- NCT number
- NCT04818060
What you commit to
- Study type: Observational
- Participants enrolled: 258
- From Sept 2021 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with phenothiazine-derivative antiemetic medications such as prochlorperazine, metoclopramide, promethazine and Inapsine greater than 3 times per month
Other illness
- 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)
- History of serious alcohol or drug abuse within the past year
Lab values
- 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
Other
- Unable to fast (no food or drink, only water) overnight before the lumbar puncture
Who the study is looking for
- 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).
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.