Virtual Reality Cognitive Therapy for Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT05788848
• Lead Sponsor: Claritytek, Inc.

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.

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-29
• Study Start: 2023-03-31
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

HealthPartners; 🇺🇸 Saint Paul, Minnesota, United States