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:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT04515550
Eligibility Criteria:
Inclusion Criteria:
* Age 20 to 85
* Montreal Cognitive Assessment score \>10
* HD subjects had onset of HD symptoms after the age of 20
* HD subjects with Diagnostic Confidence Level (DCL) of 0-3 (pre-symptomatic or pre-manifest) must have at least 40 CAG repeats on one HTT allele
* HD subjects with Diagnostic Confidence Level (DCL) of 4 (manifest) must have at least 36 CAG repeats on one HTT allele
* Controls are asymptomatic without family history of HD or have \<36 CAG repeats on both HTT alleles with family history of HD
Exclusion Criteria:
* HD subjects who did not already have genetic testing are excluded from this study
* Pregnancy or plans to become pregnant during the study
* Investigational drugs within 3 months of screening visit
* Alcohol or illicit drug abuse or dependence
* Other genetic or neurological disorders
* Other medical or psychiatric illness that in the investigator's judgement will prevent ability to tolerate or undergo study procedures
* For those volunteering for lumbar puncture (LP), bleeding disorders or excessive bleeding, anticoagulation, aspirin if unable to safely stop taking it at least 7 days prior to LP, other antiplatelet medications, inability to tolerate LP, allergy to local anesthetic or chlorhexidine, major lumbar spine deformity, low platelets or abnormal coagulation factors PT/APTT
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT04515550
Study Brief:
Protocol Section:
NCT04515550