Development of Assessments for Later Stage HD
Status unconfirmed
Conditions studied: Huntington Disease
In brief
Later Stage HD Assessments (LSA) is an observational, multinational study aiming at developing two assessments that can be used to measure critical milestones and events during the later stages of Huntington's disease (HD). An important aspect of the evaluation will be to assess whether the assessments can be administered to a companion either in-person or remotely (i.e. by phone contact with the companion). Therefore, these assessments will be evaluated for their internal consistency, reliability and validity. Once established, these assessments may be incorporated into a large scale, global observational study of HD and/or other HD clinical studies as well as use them for planning clinical trials.
Key facts
- Study ID
- NCT04370470
- Run by
- CHDI Foundation, Inc.
- People needed
- 340
- Starts
- 2020-09-01
- Expected to finish
- 2022-03-01
- Last updated by the study team
- 2020-05-01
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must meet all the following inclusion criteria to participate in this study:
- All Participants
- Individual of either gender
- Fluent in English
- Must be willing and able to provide informed consent or have a legal representative willing and able to provide assent
- Manifest HDGEC Participants
- Must be an active participant in the Enroll-HD study. An active participant is defined as a participant who has successfully enrolled in the Enroll-HD study and completed the Enroll-HD study baseline visit.
- Age≥20 years
- CAG repeat length≥36
- DCL=4
- Inclusion score of 16 at the time of the participant's most recent Enroll-HD study visit (for inclusion score calculation, see Appendix A - Inclusion Score Calculation) Companion Participants
- Age≥18 years 2. A person who, in his/her opinion, has sufficient interface and knowledge of the Manifest HDGEC Participant's capabilities and daily activities 3. Acceptable to the Manifest HDGEC Participant and the Site Investigator or the Site Investigator's designees
You may not qualify if…
- People who meet the following criteria will be excluded from participating in this study:
- Individuals with choreic movement disorders in the context of a laboratory verified non-expansion mutation for the Huntingtin gene
- Manifest HDGEC Participants with Juvenile-onset HD (rater estimate of age of onset <20 years old)
Where it is running
- The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham — Birmingham, Alabama, United States
- Regents of the University of California, San Diego — La Jolla, California, United States
- Regents of the University of California, Los Angeles — Los Angeles, California, United States
- Rocky Mountain Movement Disorders Center, P.C — Englewood, Colorado, United States
- Rush Universiity Medical Center — Chicago, Illinois, United States
- Hereditary Neurological Disease Centre, Inc. — Wichita, Kansas, United States
- Washington University — St Louis, Missouri, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- University of Washington — Seattle, Washington, United States
- The Chancellor, Masters and Scholars of the University of Cambridge — Cambridge, Cambridgeshire, United Kingdom
- Cardiff University — Wales, Cardiff, United Kingdom
- Royal Devon and Exeter NHS Foundation Trust — Exeter, Devon, United Kingdom
- Poole Hospital NHS — Poole, Dorset, United Kingdom
- Leicestershire Partnership NHS Trust — Leicester, Leicestershire, United Kingdom
- Oxford University Hospitals NHS Foundation Trust — Oxford, Leicester, United Kingdom
- Northumberland, Tyne &Wear NHS Foundation Trust of St. Nicholas Hospital — Newcastle upon Tyne, Tyne & Wear, United Kingdom
- Birmingham and Solihull Mental Health NHS Foundation — Birmingham, West Midlands, United Kingdom
- Leeds Teaching Hospitals NHS Trust — Leeds, Yorkshire, United Kingdom
- University Hospitals Plymouth NHS Trust — Plymouth, United Kingdom
- Sheffield Children's NHS Foundation Trust — Sheffield, United Kingdom
Full record on ClinicalTrials.gov
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