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Enroll-HD: A Study for Huntington's Disease

Enroll-HD is an ongoing study collecting information from people with Huntington's Disease (HD) and those without it. This study doesn't test a specific drug or treatment. Instead, it gathers health data and biological samples (like blood) over time to help researchers better understand HD. Researchers will look at how motor skills (like movement), daily function, and problem behaviors change over about a year. You can join if you are 18 or older and either carry the HD gene mutation or do not carry it (as a control participant). The study is currently ongoing, with over 30,000 participants already enrolled.

Study design
This is an observational study, meaning researchers are watching and collecting information, not testing a specific intervention. It aims to enroll 35,000 participants.
What's involved
Participants will have annual assessments, including motor skill tests (UHDRS '99 Motor), functional assessments (UHDRS '99 Total Functional Capacity), and problem behavior assessments (PBA-s). These assessments will continue through study completion, which averages about one year.
Compensation
Not stated in the trial record.
Follow-up
Participants are assessed annually through study completion, which averages about one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01574053

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

Recruiting
Not specifiedAges 18+Observational
CHDI Foundation, Inc.
~35,000 participants
Updated 2024-02-28 on ClinicalTrials.gov

At a glance

Recruiting sites
160 of 183 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Motor Assessments: Unified Huntington's Disease Rating Scale (UHDRS) 99 Motor, UHDRS '99 Diagnostic Confidence Level
Measured over through study completion, an average of 1 year
+3 more outcomes measured

Conditions

Huntington's Disease

Explore related trials

Huntington's DiseaseHTT Gene

NCT01574053

Where you'd take part

This study runs at 183 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albany Medical College

    Albany, New Yorkstudy coordinator listed

    Recruiting

  • Auckland City Hospital

    Auckland, New Zealandstudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Sant'Andrea

    Rome, Italystudy coordinator listed

    Recruiting

  • Bari Policlinico General Hospital

    Bari, Italystudy coordinator listed

    Recruiting

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

    Recruiting

  • Beaumont Hospital

    Dublin, Republic of Ireland, Irelandstudy coordinator listed

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Betsi Cadwaladr University Health Board

    Wrexham, UK, United Kingdomstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bernhard G Landwehrmeyer, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Ulm
  • Jamie Levey · STUDY_DIRECTOR · CHDI Foundation, Inc.

Who to contact

Noopur Modi
[email protected]
Email the study team

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Eligibility criteria

Inclusion

Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.
Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.
Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.
Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.
Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.
Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).
Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies.
Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.).

What this trial measures

  • Motor Assessments: Unified Huntington's Disease Rating Scale (UHDRS) 99 Motor, UHDRS '99 Diagnostic Confidence Levelthrough study completion, an average of 1 year

    The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. UHDRS 99 Motor, UHDRS Diagnostic Confidence Level.

  • Functional Assessments: UHDRS '99 Total Functional Capacity, UHDRS '99 Functional Assessment Scale, UHDRS '99 Independence Scalethrough study completion, an average of 1 year

    The Total Functional Capacity, Functional Assessment and Independence Subscales of the UHDRS '99 will be used to assess participants' functional status. The Total Functional Capacity scale has established psychometric properties including inter-rater reliability and validity, based on radiographic measures of disease progression.

  • Problem Behaviors Assessment-Short (PBA-s)through study completion, an average of 1 year

    The Problem Behavioral Assessment Short Version (PBA-s) will be used to perform behavioral assessments. This instrument measures frequency and severity of symptoms related to altered affect, thought content and coping styles.

  • Cognitive Assessments: Symbol Digit Modality Test; Stroop Color Naming; Stroop Word Reading; Categorical Verbal Fluencythrough study completion, an average of 1 year

    Cognition will be assessed using the Categorical Verbal Fluency Test, Symbol Digit Modality Test and Stroop Color and Word Reading Test. Verbal fluency is a commonly used neuropsychological test which examines the ability to spontaneously produce words orally within a fixed time span. For category fluency, words must be produced according to semantic constraints. The measure of performance used will be the number of correctly generated words within 60 seconds.