Longitudinal Endpoint Assessment of Disease Burden in HD

NCT06475898 | Recruiting

• 1 other identifier: LEAD-HD
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (3)

• PRO natural history

  Obtain PRO natural history data in HD.

  December 2026

• Demographic characteristics

  Identify demographic characteristics that are associated with faster or slower disease progression.

  December 2026

• Assess the ability to consent and enroll

  Assess the ability to consent and enroll participants in long-term longitudinal studies in HD using a direct-to-patient platform.

  December 2026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Huntington Study Group: lead
• University of Rochester Center for Health + Technology: collaborator
• Modality.AI, Inc: collaborator
• Neurotargeting LLC: collaborator

Study Sites (1)

Huntington Study Group

Rochester, New York, 14618, United States

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jamison Seabury

  University of Rochester Center for Health + Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Falanga

CONTACT

800-487-7671; info@myhdstory.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2026

Locations

US (1)