Virtual Reality Cognitive Therapy for Alzheimer's Disease

NCT05788848 | Completed Phase 1

• 2 other identifiers: A21-230R43AG076169
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Instrumental Activities of Daily Living (IADL) performance

  from baseline at 7 weeks

• Cognitive Impairment (CI)

  from baseline at 7 weeks

• Anxiety and Depression

  from baseline at 7 weeks

Interventions

VRCT BEHAVIORAL

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.

Eligibility Criteria

• Age: 30 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Claritytek, Inc.: lead
• HealthPartners Institute: collaborator

Study Sites (1)

HealthPartners

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Leah R Hanson, PhD

  HealthPartners Neuroscience Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: March 31, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 31, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

US (1)