NCT06546488 · Ohio State University
Cognitive Assessment Tools for Huntington's Disease.
(CAT-HD)
What this study is about
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).
View original scientific description
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.
Interventions
BEHAVIORAL
Assessments
A standardized assessment battery will be administered. It will consist of cognitive, functional and motor assessments.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Columbus, Ohio
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations