Virtual Reality Cognitive Therapy for Alzheimer's Disease

Study Overview
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Brief Summary
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To evaluate the usability, feasibility, and acceptability of VRCT iteratively on 36 AD/ADRD individuals with mild to moderate CI.

Detailed Description
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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.

Official Title
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Virtual Reality Cognitive Therapy for Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: VRCT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: VRCT|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Patient-Reported Simulator Sickness and System Usability using The Simulator Sickness Questionnaire and System Usability Scale Questionnaire | from baseline at 7 weeks | 
| Acceptability of Virtual Reality Cognitive Training (VRCT) for Alzheimer's Patients: Assessment of Patient-Reported Acceptability using Free-Form Suggestion Feedback | Patient-reported Acceptability of VRCT using Free-Form Suggestion Feedback such as acceptable, not acceptable or acceptable with changes. | from baseline at 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Activities of Daily Living (IADL) performance | The IADL performance measured by change in The Lawton IADL performance | from baseline at 7 weeks | 
| Cognitive Impairment (CI) | Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ) | from baseline at 7 weeks | 
| Anxiety and Depression | 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. | from baseline at 7 weeks |