Cognitive Assessment Tools for Huntington's Disease.

Not yet recruiting

• Conditions: Huntington Disease
• Interventions: Behavioral: Assessments

• Registration Number: NCT06546488
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Start: 2025-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject population	Assessments	All subjects who meet the inclusion/exclusion criteria for the trial.

Primary Outcome Measures

Name	Time	Method
Symbol Digit Modality Test (SDMT) compared to the Coding Test	One day visit	Comparison of scores on Symbol Digit Modality Test (SDMT) and Coding Test. Associations will be investigated using Spearman correlations.
Self-Administered Gerocognitive Examination (SAGE) score compared to the Symbol Digit Modality Test (SDMT) and the Stroop Word reading scores	One day visit	Comparison of SAGE score with the SDMT and the Stroop Word reading scores. (The two neuropsychological scores used in the UHDRS that have shown the best correlation with HD disease onset and progression). Associations will be investigated using Spearman correlations.

Secondary Outcome Measures

Name	Time	Method
Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores.	One day visit	Comparison of Luria test scores and SDMT vs coding scores. The Luria test is a sub-score of the Unified Huntington's Disease Rating Scale (UHDRS) motor exam and is considered marker of cognitive motor skill. Associations will be investigated using Spearman correlations.
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).	One day visit	Comparison of Total Motor Chorea sub-score, a part of the UHDRS total score and scores on the SDMT, coding and SAGE.Severity of chorea involuntary movements that are common in HD might affect ability to complete either test as both the DSC and the SAGE require fine motor and drawing skills. Associations will be investigated using Spearman correlations.
Correlation of age of HD symptom onset and SAGE scores	One day visit	Assess correlation of age of HD symptom onset and SAGE scores

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States