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OpenTrials
Completed

NCT Number: NCT05788848

Virtual Reality Cognitive Therapy for Alzheimer's Disease

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

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Key information

Age range

30 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HealthPartners

Saint Paul, Minnesota, 55130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VRCT

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  1. Instrumental Activities of Daily Living (IADL) performance

    Time frame: from baseline at 7 weeks

    The IADL performance measured by change in The Lawton IADL performance

  2. Cognitive Impairment (CI)

    Time frame: from baseline at 7 weeks

    Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ)

  3. Anxiety and Depression

    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.

Sponsors and collaborators

Lead sponsor

Claritytek, Inc.

Industry

Collaborators

  • HealthPartners Institute

Registry information

Acronym: VRCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2023
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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