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

C

Claritytek

Status and phase

Completed
Phase 1

Conditions

Alzheimer Disease

Treatments

Behavioral: VRCT

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05788848
A21-230
R43AG076169 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

30 to 89 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Razi Masood, MCS

Data sourced from clinicaltrials.gov

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