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Clinical Trials/NCT05788848
NCT05788848
Completed
Phase 1

Virtual Reality Cognitive Therapy for Alzheimer's Disease

Claritytek, Inc.1 site in 1 country36 target enrollmentMarch 31, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Claritytek, Inc.
Enrollment
36
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2023
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Time Frame: 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

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.

Secondary Outcomes

  • Instrumental Activities of Daily Living (IADL) performance(from baseline at 7 weeks)
  • Cognitive Impairment (CI)(from baseline at 7 weeks)
  • Anxiety and Depression(from baseline at 7 weeks)

Study Sites (1)

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