Dana Jeffrey Plude
$445,324
CLARITYTEK, INC.
Minnesota
National Institute on Aging (NIA)
Alzheimer’s disease (AD) and AD Related Dementias (ADRD) currently affect more than 5.8 million Americans, costing $305 billion 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 brain targeting methods to assist AD/ADRD patients is imperative. After the COVID-19 pandemic impact on AD patients, we believe there is a growing need for identifying more effective non-invasive digital Cognitive Impairment (CI) interventions that are easily adapted and remotely accessible within the person’s home. ClarityTek proposes to develop Virtual Reality Cognitive Therapy (VRCT) that targets individualized aging needs. This therapy will be structured, based on multidisciplinary evidence, goal-directed, multicomponent, remotely administered, and designed for a broad reach. We will create a tool to restore or reorganize neural pathways to compensate for impaired cognitive function and enable mild to moderate AD patients to adapt to their new situation and improve their QOL. VRCT utilizes a four-pronged approach: Assess, Educate, Treat, and Track. Interventions for AD must consider all facets of cognitive deficits, especially cognitive skills impacting activities of daily living (ADL) and instrumental ADL (IADL). VR is immersive, isolating the patient from surrounding distractions -- crucial for any CI intervention. VRCT training activities generalized to real life, tailored to engage, adapt, and challenge, will simulate realistic CI-producing scenarios in contexts where these occur. Within VRCT, repeated CI scenario exposure through game loops will gradually train the patients in practical skills to navigate everyday situations: medical appointments, taking medications, shopping, recognizing names and faces, and directions to places. Preserving these skills will improve functional independence. The VRCT intervention aims to remediate IADL specific disabilities. It will include an optional integration that makes possible asynchronous online therapist consultations without face-to-face contact, important during the COVID-19 pandemic. VRCT for Alzheimer’s with CI ranked among the world’s top 5 innovations in an international digital health competition. In this Phase I project, we will partner with groups at the HealthPartners Neuroscience Center with Alzheimer’s research and practice expertise to lead the trial and help design, develop, and optimize VRCT for AD patients. We will incorporate stakeholder feedback to create a patient-centric intervention targeting four specific prioritized CI related to IADL, utilizing the digital therapy development frameworks’ guidelines. To guide the project, we will create a multidisciplinary Expert Focus Group. In Aim 1, we will evaluate the feasibility, usability, acceptability, and the initial clinical efficacy 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 n=36 participants. Each trial’s results will be applied iteratively in Aim 2 to revise the VRCT, producing the most effective CI intervention. In Aim 2, we will iteratively redesign, develop, unit test, and optimize VRCT with the patients’ feedback from the trials and guidance from the Expert Focus Group. We expect to establish that VRCT will be feasible, usable, and acceptable with a Usability Scale success rate of 90%, user satisfaction of 80%, and improved cognition.