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NCT Number: NCT06546488

Cognitive Assessment Tools for Huntington's Disease.

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location status: Recruiting

Location contact

Nicole Vrettos

CONTACT

Sandra Kostyk, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Assessments

Behavioral

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

Primary outcomes

  1. Symbol Digit Modality Test (SDMT) compared to the Coding Test

    Time frame: One day visit

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

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. 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).

    Time frame: 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.

  3. Correlation of age of HD symptom onset and SAGE scores

    Time frame: One day visit

    Assess correlation of age of HD symptom onset and SAGE scores

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole E Vrettos

CONTACT

[email protected]

6143668642

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Cognitive Assessment Tools for Individuals With Huntington's Disease.

Acronym: CAT-HD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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