Clinical trial NCT05788848: Virtual Reality Cognitive Therapy for Alzheimer's Disease
Official title: Virtual Reality Cognitive Therapy for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Claritytek, Inc.
Sponsor class: INDUSTRY
Collaborators: name: HealthPartners Institute
First posted: 2023-03-29
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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
timeFrame: from baseline at 7 weeks
measure: Acceptability of Virtual Reality Cognitive Training (VRCT) for Alzheimer's Patients: Assessment of Patient-Reported Acceptability using Free-Form Suggestion Feedback
timeFrame: from baseline at 7 weeks
Secondary outcomes:
measure: Instrumental Activities of Daily Living (IADL) performance
timeFrame: from baseline at 7 weeks
measure: Cognitive Impairment (CI)
timeFrame: from baseline at 7 weeks
measure: Anxiety and Depression
timeFrame: from baseline at 7 weeks
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners
state: Minnesota
Study officials:
affiliation: HealthPartners Neuroscience Center
name: Leah R Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References: