Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT04818060
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04818060
Study Brief:
Protocol Section:
NCT04818060