Cognitive Assessment Tools for Huntington's Disease.
ConditionHuntington Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-65
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Huntington disease patients with a clinical diagnosis.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Assessments
BehavioralA standardized assessment battery will be administered. It will consist of cognitive, functional and motor assessments.
Treatment groups
76 Participants
are divided into 1 treatment groupGroup A: Subject population1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
One day visit2
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.
Time frame
One day visitSecondary outcomes
1
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.
Time frame
One day visit2
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.
Time frame
One day visit3
Correlation of age of HD symptom onset and SAGE scores
Assess correlation of age of HD symptom onset and SAGE scores
Time frame
One day visitSponsors and contacts
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Source ClinicalTrials.gov