Cognitive Assessment Tools for Huntington's Disease.

NCT06546488 | Recruiting

• 1 other identifier: 2024H0192
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease

Keywords

Self-Administered Gerocognitive Examination (SAGE); Coding; Huntington Disease

Outcome Measures

Primary Outcomes (2)

• Symbol Digit Modality Test (SDMT) compared to the Coding Test

  Comparison of scores on Symbol Digit Modality Test (SDMT) and Coding Test. Associations will be investigated using Spearman correlations.

  One day visit

• Self-Administered Gerocognitive Examination (SAGE) score compared to the Symbol Digit Modality Test (SDMT) and the Stroop Word reading scores

  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.

  One day visit

Secondary Outcomes (3)

• Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores.

  One day visit

• 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

• Correlation of age of HD symptom onset and SAGE scores

  One day visit

Study Arms (1)

Subject population

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

Behavioral: Assessments

Interventions

Assessments BEHAVIORAL

A standardized assessment battery will be administered. It will consist of cognitive, functional and motor assessments.

Subject population

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Huntington disease patients with a clinical diagnosis.

You may qualify if:

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

You may not qualify if:

• Age of symptom onset less than 19 years old or greater than 60 years old.
• 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.
• 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).
• Subjects who are pregnant or breast feeding
• Subjects with a history of a learning disability.
• Subjects who are unable to provide consent.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Nicole E Vrettos

CONTACT

6143668642; nicole.vrettos@osumc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Neurology

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 9, 2024
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)