Longitudinal Endpoint Assessment of Disease Burden in HD (LEAD-HD)

September 9, 2025 updated by: Huntington Study Group
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14618
        • Recruiting
        • Huntington Study Group
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Must self-report they have been diagnosed with HD by a doctor or have undergone genetic testing, been found to carry the expanded allele responsible for HD and have no clinical diagnosis (prodromal HD) (HD-ISS Stage 2 or 3).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huntington Study Group

Collaborators

Neurotargeting LLC
University of Rochester Center for Health + Technology
Modality.AI, Inc

Investigators

  • Principal Investigator: Jamison Seabury, University of Rochester Center for Health + Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEAD-HD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The accrued data will help create a patient-reported natural history of HD, clinically meaningful outcomes for clinical trials, a resource to enable respondents to participate in future research, and a shared longitudinal database for researchers to access and analyze de-identified data and publish findings.

IPD Sharing Time Frame

2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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