FuRST 2.0 Cognitive Pre-Testing

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02881931
• Date of registration: 12/08/2016
• Prospective Registration: Yes
• Primary sponsor: CHDI Foundation, Inc.
• Public title: FuRST 2.0 Cognitive Pre-Testing
• Scientific title: FuRST 2.0: Cognitive Pre-Testing Study for a New Functional Rating Scale for Use in Huntington's Disease
• Date of first enrolment: February 28, 2017
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02881931
• Study type: Observational
• Phase: N/A

Countries of recruitment

Canada, United States

Key inclusion & exclusion criteria

Main criteria for inclusion:

1. HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)

2. At least 18 years of age

3. Must be fluent in English and had his primary education in English

4. Must be willing and able to provide written informed consent

Pre-Manifest HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 40

2. Disease Burden Score greater than or equal to 250 (calculated by the equation:

[CAGn-35.5] X age)

3. UHDRS Diagnostic Confidence Level (DCL) < 3

4. At least five Pre-Manifest HDGEC participants should have a companion who is willing
to participate in this study and complete the scale independently.

Early-Manifest (Stage 1&2) HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 36

2. DCL=4

3. UHDRS Total Functional Capacity (TFC) =7

4. Participants whose companion is willing to participate in this study and complete the
scale independently

Main criteria for exclusion:

1. Significant cognitive or any other impairment sufficient to interfere with study
associated tasks as judged by the study Investigator or the Investigator's designee

2. Currently participating in a clinical trial involving an investigational medicinal
product



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Behavioral: FuRST 2.0

Primary Outcome(s)

Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis [Time Frame: 8 months]

Secondary Outcome(s)

The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale [Time Frame: 8 months]

Secondary ID(s)

C-000316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The University of Texas Health Science Center, Houston

Dr. Glenn T. Stebbins (Rush University Medical Center )

Nancy LaPelle