HealthPartners
Saint Paul, Minnesota, 55130, United States
NCT Number: NCT05788848
To evaluate the usability, feasibility, and acceptability of VRCT iteratively on 36 AD/ADRD individuals with mild to moderate CI.
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Notify Me30 year–89 year
All sexes
Interventional
Phase 1
Saint Paul, Minnesota, 55130, United States
Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD) resulting in cognitive decline affects more than 5.8 million Americans. Given the impact on quality of life, there is a great need for therapies focused on cognition. In this study, we will test the feasibility, usability, and acceptability of a novel Virtual Reality Cognitive Therapy (VRCT) for AD developed by ClarityTek, Inc. The VRCT will focus primarily on skills that impact instrumental activities of daily living (e.g., taking medications, shopping). Thirty-six individuals with mild to moderate AD/ADRD will be enrolled and will utilize the VRCT over seven weeks within their home. Enrollment will occur in cohorts of 12 individuals, so that the VRCT can be revised and optimized based on the results, prior to the next cohort. We will also hold Expert Focus Groups with clinician specialists to obtain feedback for improvement.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The VRCT will focus primarily on skills that impact instrumental activities of daily living (e.g., taking medications, shopping). Thirty-six individuals with mild to moderate AD/ADRD will be enrolled and will utilize the VRCT over seven weeks within their home.
Time frame: from baseline at 7 weeks
Patient-Reported Simulator Sickness and System Usability using The Simulator Sickness Questionnaire and System Usability Scale Questionnaire
Time frame: from baseline at 7 weeks
Patient-reported Acceptability of VRCT using Free-Form Suggestion Feedback such as acceptable, not acceptable or acceptable with changes.
Time frame: from baseline at 7 weeks
The IADL performance measured by change in The Lawton IADL performance
Time frame: from baseline at 7 weeks
Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ)
Time frame: from baseline at 7 weeks
Anxiety and Depression will also be measured by change in the Hospital Anxiety-Depression Scale (HADS) to monitor as a potential confounder of cognition and function.
Claritytek, Inc.
Industry
Acronym: VRCT
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