Cognitive Assessment Tools for Huntington's Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assessments.
- Who it may be relevant to
- Registry conditions: Huntington Disease. Basic parameters: 30 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive Assessment Tools for Individuals With Huntington's Disease.
Overview
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.
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]
- 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- The Ohio State University Wexner Medical Center — Columbus
Identifiers
NCT: NCT06546488 · 2024H0192