Clinical trial NCT06546488: Cognitive Assessment Tools for Huntington's Disease.
Official title: Cognitive Assessment Tools for Individuals With Huntington's Disease.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Huntington Disease
Keywords: Self-Administered Gerocognitive Examination (SAGE)
Coding
Huntington Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Huntington disease patients with a clinical diagnosis.

Brief summary: 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 Coding Test and the other is the Self-Administered Gerocognitive Examination (SAGE). Both the Coding Test 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symbol Digit Modality Test (SDMT) compared to the Coding Test
timeFrame: One day visit
measure: Self-Administered Gerocognitive Examination (SAGE) score compared to the Symbol Digit Modality Test (SDMT) and the Stroop Word reading scores
timeFrame: One day visit
Secondary outcomes:
measure: Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores.
timeFrame: One day visit
measure: Comparison of Total Motor Chorea sub-score, a part of the Unified Huntington's Disease Rating Scale (UHDRS) total score and scores on the Symbol Digit Modality Test (SDMT), Coding and Self-Administered Gerocognitive Examination (SAGE).
timeFrame: One day visit
measure: Correlation of age of HD symptom onset and SAGE scores
timeFrame: One day visit
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: