VRCT: Virtual Reality Cognitive Therapy for Alzheimer's Disease

• Sponsor: Claritytek, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05788848
• Collaborator: HealthPartners Institute (Other)
• Enrollment: 36
• Location: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Behavioral: VRCT	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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 (Participant)
• 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)
• Primary Purpose: Treatment
• Official Title: Virtual Reality Cognitive Therapy for Alzheimer's Disease
• Actual Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Sep 20, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Outcome Measures

Primary Outcome Measures

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 [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 [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

1. Instrumental Activities of Daily Living (IADL) performance [from baseline at 7 weeks]

   The IADL performance measured by change in The Lawton IADL performance

2. Cognitive Impairment (CI) [from baseline at 7 weeks]

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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HealthPartners	Saint Paul	Minnesota	United States	55130

Sponsors and Collaborators

• Claritytek, Inc.
• HealthPartners Institute

Investigators

• Principal Investigator: Leah R Hanson, PhD, HealthPartners Neuroscience Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claritytek, Inc.
• ClinicalTrials.gov Identifier: NCT05788848
• Other Study ID Numbers: A21-230; R43AG076169
• First Posted: Mar 29, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Apr 3, 2023