Rochester, NY, July 15, 2024 - The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) today announce the release of their newest Patient Reported Outcomes (PRO) study, LEAD-HD. This observational study was developed collaboratively with the University of Rochester Center for Health + Technology to gain deeper insight into Longitudinal Endpoints Assessment of Disease Burden in Huntington’s disease (HD).
LEAD-HD is the newest addition to HSG’s online research platform, myHDstory®, which was launched in 2022 to enable adults with HD or prodromal HD to share their personal experiences with the disease from the privacy and comfort of their homes.
The pilot study on the platform, Making HD Voices Heard, was a groundbreaking initiative that successfully engaged individuals with HD who reported that they had never participated in a clinical research study before. In addition, the study cohort achieved higher racial diversity and geographic representation than seen in prior HD studies.
LEAD-HD will expand on the pilot study in a longitudinal design using the Huntington’s Disease-Health Index (HD-HI), the HD-PROP, and measures for both total functional capacity (TFC) and health literacy (HLQ19-Q12). The goals of LEAD-HD are to obtain natural history data in HD, identify demographic characteristics that are associated with faster or slower disease progression, and obtain longitudinal performance metrics of the HD-HI that will facilitate its implementation in future clinical trials.
Dr. Andrew Feigin, HSG Chief Medical Officer said, “Historically, participation in observational studies has required in-person visits with a clinician at a clinical or research site, which creates barriers for many people and decreases participation in this vital form of research. Observational studies help create a better understanding of the natural history of HD, clinically meaningful outcomes for clinical trials, and can provide a resource to enable respondents to participate in future research.”
"LEAD-HD is the first study to use the HD-HI in a direct-to-participant, online platform and we believe the first to examine health literacy among people with HD,” said Jamison Seabury, PhD student in translational biomedical science at the University of Rochester and the Study Principal Investigator. “This is an exciting step for HD research.”
The LEAD-HD study is now enrolling eligible participants. To learn more, visit https://huntingtonstudygroup.org/study/lead-hd/.
About Huntington Study Group
The Huntington Study Group® (HSG®), a not-for-profit organization founded in 1993 in Rochester, NY, and its wholly owned subsidiary, HSG Clinical Research, Inc., are world leaders in designing and conducting clinical trials through the world’s first and largest collaborative network with thousands of members at more than 130 HSG credentialed research sites worldwide. HSG conducted all three pivotal clinical trials that led to the only FDA-approved medications for Huntington's disease associated chorea. The organization is dedicated to improving the lives of people impacted by Huntington’s disease through research, education, and collaboration. For more information, visit https://huntingtonstudygroup.org/.
About Huntington’s Disease
Huntington’s disease (HD) is a progressive hereditary neurodegenerative disease characterized by movement disorders, psychiatric difficulties, and cognitive changes. HD symptoms usually present in middle adult life but can begin at any age. HD is a rare disorder -- about 200,000 people worldwide have been diagnosed but many more are at risk for inheriting the disease from a parent. Huntington’s disease impacts people of all genders, races, and ethnicities. While symptomatic treatments are available, a cure for HD has not yet been discovered.
About UR Center for Health + Technology [CHeT]
For more than three decades, CHeT has served as a worldwide leader in the conduct, planning, management, implementation, analysis, and rescuing of large multi-center clinical research studies. Simultaneously, our innovative and novel technologies and outcome measures have shaped and improved how research is conducted and how therapies are evaluated.
About Huntington's Disease Health Index (HD-HI)
The Huntington's Disease Health Index (HD-HI) is a novel, validated, disease-specific, patient-reported outcome measure designed to evaluate clinically meaningful changes in Huntington's disease (HD) burden in response to therapeutic interventions. HD-HI includes a total-score measurement of patient-reported disease burden and 13 subscales: mobility, involuntary movements, hand and arm function, emotional health, activity participation, social performance, social satisfaction, fatigue, pain, cognition, communication, swallowing function, and sleep and daytime sleepiness. This multifaceted patient-reported outcome measure (PROM) was designed, developed, and validated at the Center for Health and Technology (CHeT), a clinical research organization within the University of Rochester Medical Center with the support of HSG.
Contact
Huntington Study Group
Emma Berkner
800-487-7671
https://huntingtonstudygroup.org
