Cognitive Assessment Tools for Huntington's Disease. (CAT-HD)

The Ohio State University

Status: Not yet enrolling

Conditions: Huntington Disease

Treatments: Behavioral: Assessments

Study type: Observational

Funder types: Other

Identifiers

NCT06546488

2024H0192

Details and patient eligibility

About

The purpose of the current proposal is to expand understanding of two currently available cognitive tools that are not typically used in Huntington Disease (HD) clinical trials that might be useful both for initial screening and for clinical trial application. One is the Digit Symbol Coding Test (DSC) and the other is the Self-Administered Gerocognitive Examination (SAGE). Both the DSC and the SAGE have been used for assessments of individuals with other neurodegenerative diseases, including Alzheimer's Disease, Parkinson's Disease and Lewy Body Disease, but data is lacking on their use in individuals with HD.

Full description

Subjects will be recruited from the OSU Wexner Medical Center Huntington Society of America Center of Excellence Clinic. Subjects will be scheduled for a one-time visit to complete the study. The entire visit will take approximately 1-1.5 hours. Vital signs (weight, blood pressure, temperature, respiratory rate and pulse) will be conducted. The subject's medical records will be reviewed to obtain their demographics, current medications, medical/surgical/ HD family history, and HD diagnosis details. If any adverse events occur during the research visit they will be documented. Participants will complete cognitive, functional and motor assessments.

Enrollment: 76 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females aged 30-65 (inclusive) at the time of signing the informed consent form.
2. Genetic diagnosis of HD as defined by a CAG repeat size ≥ 40.
3. A clinical diagnosis of HD as defined by a Diagnostic Confidence Level (DCL) of 4.
4. Vision and hearing sufficient for compliance with tests.
5. On a stable dose of medications for 30 days prior to the time of signing the informed consent form.

Exclusion criteria

1. Age of symptom onset less than 19 years old or greater than 60 years old.
2. Any serious neurological disorder aside from HD, including but not limited to Alzheimer's disease, Parkinson's disease, Frontotemporal dementia, Lewy body dementia, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury... etc. that in the opinion of the investigator is clinically significant.
3. Any ongoing serious medical condition that in the opinion of the investigator is clinically significant. This includes autoimmune diseases, ongoing treatment for cancer, congestive heart failure, severe pulmonary disease, or any history of a seizure disorder (including the need to take anti-epileptics to prevent seizure).
4. Subjects who are pregnant or breast feeding
5. Subjects with a history of a learning disability.
6. Subjects who are unable to provide consent.

Trial design

76 participants in 1 patient group

Subject population

Description:

All subjects who meet the inclusion/exclusion criteria for the trial.

Treatment:

Behavioral: Assessments