Huntington DiseaseLEAD-HDNCT06475898
Longitudinal Endpoint Assessment of Disease Burden in HD
An observational study of Huntington Disease, run by Huntington Study Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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;
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- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntington Study Group
Rochester, New York, 14618
Lauren Falanga, 800-487-7671, info@myhdstory.org
About this study
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.
Read the 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.
- Conditions
- Huntington Disease
- Medical subject headings
- Huntington Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
PRO natural history
Obtain PRO natural history data in HD.
Measured: December 2026
Demographic characteristics
Identify demographic characteristics that are associated with faster or slower disease progression.
Measured: 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.
Measured: December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start25 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huntington Study Group
- Sponsor type
- Research network
- Collaborators
- University of Rochester Center for Health + Technology, Modality.AI, Inc, Neurotargeting LLC
- Responsible party
- Sponsor
- Investigators
- Jamison Seabury, Principal investigator, University of Rochester Center for Health + Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475898
- Sponsor's protocol ID
- LEAD-HD
- Acronym
- LEAD-HD
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Endpoint Assessment of Disease Burden in HD
- ClinicalTrials.gov ID
- NCT06475898
- Acronym / sponsor ID
- LEAD-HD / LEAD-HD
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Huntington Study GroupResearch network
- Collaborators
- University of Rochester Center for Health + Technology, Modality.AI, Inc, Neurotargeting LLC
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PRO natural history
Time frame: December 2026
Obtain PRO natural history data in HD.
Demographic characteristics
Time frame: December 2026
Identify demographic characteristics that are associated with faster or slower disease progression.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamison Seabury principal investigator
University of Rochester Center for Health + Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Huntington Study Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Falanga (800-487-7671, info@myhdstory.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRO natural history (time frame: December 2026). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.