Virtual Reality Cognitive Therapy for Alzheimer's Disease

Alzheimer Disease Clinical Trial

— VRCT  

Official title:

Virtual Reality Cognitive Therapy for Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788848
• Other study ID #: A21-230
• Secondary ID: R43AG076169
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Claritytek, Inc.
• Contact: Razi Masood, MCS
• Phone: 6125677867
• Email: razi.masood[@]claritytek.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 30, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Claritytek, Inc.	HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Instrumental Activities of Daily Living (IADL) performance	The IADL performance measured by change in The Lawton IADL performance	from baseline at 7 weeks
Secondary	Cognitive Impairment (CI)	Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ)	from baseline at 7 weeks
Secondary	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