Status:
UNKNOWN
Development of Assessments for Later Stage HD
Lead Sponsor:
CHDI Foundation, Inc.
Conditions:
Huntington Disease
Eligibility:
All Genders
20+ years
Brief Summary
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 Hun...
Detailed Description
The primary objective of this study is to evaluate the internal consistency, reliability and validity of two assessments: (1) UHDRS Structured Interview of Function (SIF) that incorporates the UHDRS T...
Eligibility Criteria
Inclusion
- 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
- 1\. 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT04370470
Start Date
September 1 2020
End Date
March 1 2022
Last Update
May 1 2020
Active Locations (20)
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1
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Regents of the University of California, San Diego
La Jolla, California, United States, 92037
3
Regents of the University of California, Los Angeles
Los Angeles, California, United States, 90095
4
Rocky Mountain Movement Disorders Center, P.C
Englewood, Colorado, United States, 80113