Alzheimer Disease
Conditions
Brief summary
To evaluate the usability, feasibility, and acceptability of VRCT iteratively on 36 AD/ADRD individuals with mild to moderate CI.
Detailed description
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.
Interventions
BEHAVIORALVRCT
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.
Sponsors
HealthPartners Institute
Claritytek, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This study is a phase I, feasibility study for research and development of a product. We will use a single group, pre-post study design. Individuals with mild to moderate CI (diagnosis of mild cognitive impairment (MCI), probable Alzheimer's disease (AD), or Alzheimer's disease Related Dementias (ADRD)
Intervention model description
This study is a phase I, feasibility study for research and development of a product. We will use a single group, pre-post study design.
Eligibility
Sex/Gender
ALL
Age
30 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild cognitive impairment (MCI), probable Alzheimer's disease (AD) or Alzheimer's disease Related Dementias (ADRD) * Montreal Cognitive Assessment (MoCA) score of 11-25 * Age 30-89
Exclusion criteria
* Non-English speaking * History of seizure disorder, vertigo disorder, or severe motion sickness that would impact their ability to participate in the intervention * History of any other serious condition that may limit their ability to participate in the intervention, as determined by the investigators. * Inability to use the VR device (e.g., severe visual/hearing impairment, aphasia, facial injuries)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Usability of Virtual Reality Cognitive Therapy (VRCT) for Alzheimer's Patients: Assessment of Patient-Reported Simulator Sickness and System Usability using The Simulator Sickness Questionnaire and System Usability Scale | from baseline at 7 weeks | Patient-Reported Simulator Sickness and System Usability using The Simulator Sickness Questionnaire and System Usability Scale Questionnaire |
| Acceptability of Virtual Reality Cognitive Training (VRCT) for Alzheimer's Patients: Assessment of Patient-Reported Acceptability using Free-Form Suggestion Feedback | from baseline at 7 weeks | Patient-reported Acceptability of VRCT using Free-Form Suggestion Feedback such as acceptable, not acceptable or acceptable with changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instrumental Activities of Daily Living (IADL) performance | from baseline at 7 weeks | The IADL performance measured by change in The Lawton IADL performance |
| Cognitive Impairment (CI) | from baseline at 7 weeks | Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ) |
| Anxiety and Depression | 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. |
Countries
United States
Outcome results
None listed