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Virtual Reality Cognitive Therapy for Alzheimer's Disease (VRCT)

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VRCT
Sponsored by
Claritytek, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

30 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • HealthPartnersRecruiting

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Instrumental Activities of Daily Living (IADL) performance
The IADL performance measured by change in The Lawton IADL performance
Cognitive Impairment (CI)
Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ)
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.

Full Information

First Posted
March 15, 2023
Last Updated
September 24, 2023
Sponsor
Claritytek, Inc.
Collaborators
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05788848
Brief Title
Virtual Reality Cognitive Therapy for Alzheimer's Disease
Acronym
VRCT
Official Title
Virtual Reality Cognitive Therapy for Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Claritytek, Inc.
Collaborators
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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.
Masking
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)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
VRCT
Intervention Description
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 Outcome Measure Information:
Title
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
Description
Patient-Reported Simulator Sickness and System Usability using The Simulator Sickness Questionnaire and System Usability Scale Questionnaire
Time Frame
from baseline at 7 weeks
Title
Acceptability of Virtual Reality Cognitive Training (VRCT) for Alzheimer's Patients: Assessment of Patient-Reported Acceptability using Free-Form Suggestion Feedback
Description
Patient-reported Acceptability of VRCT using Free-Form Suggestion Feedback such as acceptable, not acceptable or acceptable with changes.
Time Frame
from baseline at 7 weeks
Secondary Outcome Measure Information:
Title
Instrumental Activities of Daily Living (IADL) performance
Description
The IADL performance measured by change in The Lawton IADL performance
Time Frame
from baseline at 7 weeks
Title
Cognitive Impairment (CI)
Description
Cognitive Impairment measured by change in the Cognitive Failures Questionnaire (CFQ)
Time Frame
from baseline at 7 weeks
Title
Anxiety and Depression
Description
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.
Time Frame
from baseline at 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Razi Masood, MCS
Phone
6125677867
Email
razi.masood@claritytek.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah R Hanson, PhD
Organizational Affiliation
HealthPartners Neuroscience Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarissa Howe (study coordinator)
Phone
651-495-6363
Email
ClinicalTrials@HealthPartners.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Virtual Reality Cognitive Therapy for Alzheimer's Disease

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