Dana Jeffrey Plude
$55,000
CLARITYTEK, INC.
Minnesota
National Institute on Aging (NIA)
Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD) currently affect more than 5.8 million Americans, costing $305 billion for treatment and management in 2020 and causing poor outcomes such as loss of independence, low quality of life, and nursing home requirements. Given the scale of diminished health-related quality of life, the need for non-invasive customizable cognitive impairment (CI) targeting methods to assist AD patients is imperative. There is a significant need for effective individualized digital interventions for AD patients accessible with social distancing in the COVID-19 pandemic situation. Claritytek proposes to develop an evidence-based, non-invasive, novel tool targeting individual aging cognitive deficits to improve AD/ADRD patients' quality of life. Virtual Reality Cognitive Therapy (VRCT) utilizes a four- pronged approach: Assess, Educate, Treat, and Track. VR is immersive, isolating the patient from surrounding distractions -- crucial for any CI intervention. Cognitive Interventions for AD should consider all facets of cognitive deficits, especially skills impacting activities of daily living (ADL) and IADL (instrumental ADL). VRCT aims to treat IADL disabilities impacting AD patients. VRCT training activities are designed to imitate real-life situations, tailored to engage, adapt, challenge, simulating lifelike CI-producing scenarios in contexts where they occur. Utilizing VRCT, repeated exposures to CI scenarios through game loops to gradually train patients in useful skills: medical appointments, taking medications, shopping, and remembering names, faces, and directions to places – to preserve and improve functional independence. Our system will include an optional mode for asynchronous online therapist consultations without face-to-face contact, valuable during COVID-19 isolations. We will expand, adapt, and build on our team’s prior successful work for Alzheimer’s patients with CI, ranked among the top 5 innovations in the world at an international digital health competition. We will partner with specialists at the HealthPartners Neuroscience Center for Alzheimer’s Research to lead the trial and help design, develop, and optimize VRCT. We will incorporate stakeholder feedback to create a patient-centric intervention targeting four specific prioritized "CI" related to IADL, utilizing guidelines of the digital therapy development frameworks. To guide the project, we will create a multidisciplinary Expert Focus Group (EFG). In Aim 1, we will evaluate the feasibility, usability, and acceptability of VRCT on 36 AD/ADRD patients with mild to moderate CI over seven weeks. We will conduct three trials, each trial with a cohort of n=12, total of n=36 participants. In addition to the patient’s responses to the therapy, a focus of the evaluation will be cognitive tolerability, as the target patients have CI. The results from each trial will be applied iteratively in Aim 2 to revise the VRCT before the next trial, producing the most acceptable CI intervention. In Aim 2, we will iteratively redesign, develop, unit test, and optimize VRCT based on patients’ feedback from the trials and EFG analysis. We expect to establish that VRCT will be feasible, usable, and acceptable with a Usability Scale success rate of 90%, and user satisfaction of 80%.