Recruiting

Cognitive Tools

Sponsor:

Ohio State University

Code:

NCT06546488

Conditions

Huntington Disease

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

Assessments

Study Details

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

Study ID

NCT06546488

Start date

Jun 20, 2025

Status verified date

Feb, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

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

Enrollment

76 participants

Anticipated

Interventions and Outcome Measures

Arms

Subject population

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

Interventions

Assessments

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

Primary outcome measure

  • Symbol Digit Modality Test (SDMT) compared to the Coding Test [ Time Frame: One day visit ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43221

Principal Investigator:

Sandra Kostyk, MD, PhD

More Information

Sponsor

Ohio State University

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-03-02.