Virtual Reality Cognitive Therapy for Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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)

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leah R Hanson, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neuroscience Center

Locations

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HealthPartners

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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R43AG076169

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A21-230

Identifier Type: -

Identifier Source: org_study_id