Huntington DiseaseCAT-HDNCT06546488
Cognitive Assessment Tools for Huntington's Disease.
An observational study of Huntington Disease, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Adult, Older adult
Study population: Huntington disease patients with a clinical diagnosis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
Nicole Vrettos
Sandra Kostyk, MD, PhD
About this study
Official title: Cognitive Assessment Tools for Individuals With 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.
Read the detailed description
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.
- Conditions
- Huntington Disease
- Being tested
- Assessments
- Keywords
- Self-Administered Gerocognitive Examination (SAGE), Coding, Huntington Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentsBehavioural
A standardized assessment battery will be administered. It will consist of cognitive, functional and motor assessments.
| Study group | Role | What they receive |
|---|---|---|
| Subject population | All subjects who meet the inclusion/exclusion criteria for the trial. Receives: Behavioral: Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One day visit
Secondary outcomes (3)
Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores.
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.
Measured: 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).
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.
Measured: One day visit
Correlation of age of HD symptom onset and SAGE scores
Assess correlation of age of HD symptom onset and SAGE scores
Measured: One day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start20 Jun 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kostyk, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546488
- Sponsor's protocol ID
- 2024H0192
- Acronym
- CAT-HD
- Status last verified
- Feb 2026
- First submitted
- 12 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Assessment Tools for Individuals With Huntington's Disease.
- ClinicalTrials.gov ID
- NCT06546488
- Acronym / sponsor ID
- CAT-HD / 2024H0192
- Conditions
- Huntington Disease
- Keywords
- Self-Administered Gerocognitive Examination (SAGE), Coding, Huntington Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject population | – | Behavioral: AssessmentsAll subjects who meet the inclusion/exclusion criteria for the trial. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Huntington disease patients with a clinical diagnosis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentsA standardized assessment battery will be administered. It will consist of cognitive, functional and motor assessments. | Behavioural | Subject population |
Primary outcome
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.
3 secondary outcomes
Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores.
Time frame: 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).
Time frame: One day visit
Correlation of age of HD symptom onset and SAGE scores
Time frame: One day visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole E Vrettos (6143668642, nicole.vrettos@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbol Digit Modality Test (SDMT) compared to the Coding Test (time frame: One day visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.