Longitudinal Endpoint Assessment of Disease Burden in HD

Recruiting

• Conditions: Huntington Disease

• Registration Number: NCT06475898
• Lead Sponsor: Huntington Study Group

Brief Summary

LEAD-HD is intended to collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD participating in a 24-month longitudinal natural history study using remote technologies.

Detailed Description

The LEAD-HD study will be offered via HSG's online observational research platform called myHDstory®. This direct to patient study will collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD in a 24-month longitudinal natural history study that participants complete at any time and with their own electronic device.

Study Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study Start: 2024-06-25
• Study First Posted: 2024-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Be 18 years of age or older;
• Be willing and able to provide informed consent electronically;
• Self-report, when answering as a participant, that you have been diagnosed with HD by a doctor, or have undergone genetic testing and been found to carry the gene mutation responsible for HD but have not been clinically diagnosed with HD (prodromal HD);
• Have the ability to answer online questions or direct someone else to enter answers for them;
• Have the ability to ambulate independently and take care of some of your personal needs;
• Have the ability to read and understand English;
• Be willing to create a unique identifier based on personal demographic information;
• Reside in the United States or its territories. Surveys can only be completed in the US. If you move outside of the US, you will no longer be able to participate;
• Own or have access to an electronic device and secure internet connectivity

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the ability to consent and enroll	December 2026	Assess the ability to consent and enroll participants in long-term longitudinal studies in HD using a direct-to-patient platform.
Demographic characteristics	December 2026	Identify demographic characteristics that are associated with faster or slower disease progression.
PRO natural history	December 2026	Obtain PRO natural history data in HD.

Trial Locations

Locations (1)

Huntington Study Group; 🇺🇸 Rochester, New York, United States