Using SAGE and a Coding test to check thinking skills in Huntington's disease

Cognitive Assessment Tools for Individuals With Huntington's Disease.

We will test whether two quick thinking tests—the Self‑Administered Gerocognitive Examination (SAGE) and a Coding test—work well for adults with genetic Huntington's disease.

Quick facts

• Study type: Observational
• Enrollment: 76 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06546488 on ClinicalTrials.gov

What this trial studies

Researchers will recruit adults with genetically confirmed Huntington's disease from the OSU Wexner Medical Center Huntington Center of Excellence for a single in-person visit lasting about 1 to 1.5 hours. During the visit participants will have vital signs recorded, medical records reviewed, and will complete cognitive, motor, and functional assessments including the SAGE and a Coding test. The project aims to expand understanding of these brief tools that are commonly used in other neurodegenerative diseases but have limited data in HD. Results will inform whether these measures could be useful for initial screening and for use in clinical trials.

Who should consider this trial

Good fit: Adults aged 30–65 with a genetic diagnosis of HD (CAG ≥ 40) and a clinical Diagnostic Confidence Level of 4, with adequate vision/hearing and stable medications, are ideal candidates.

Not a fit: People with juvenile onset (<19) or very late onset (>60), those with other significant neurological or ongoing serious medical conditions, or those unable to comply with vision/hearing requirements may not benefit or be eligible.

Why it matters

Potential benefit: If successful, these brief tools could make it easier to identify and track thinking problems in people with HD, simplifying screening and monitoring for care and trials.

How similar studies have performed: Both the SAGE and Coding tests have demonstrated usefulness in Alzheimer’s, Parkinson’s, and Lewy body disease, but their performance in Huntington’s disease is largely untested.

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.

Where this trial is running

Columbus, Ohio

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Nicole E Vrettos

Conditions Huntington Disease; Self-Administered Gerocognitive Examination; Coding