R44AG076067

Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials - Summary/Abstract:

Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) adversely impact our large and growing aging population. An estimated 5.8 million American’s 65 years and older are suffering from AD, with that number projected to hit 13.8 million by 2050.

Aging African American and Latinx populations are particularly hard-hit by AD/ADRD, as are rural communities due to lack of access to clinical trials and medical care.

A broad range of symptoms are associated with these diseases and each patient’s progression is unique and clinically quite variable. During a clinical trial, when longitudinal studies are conducted over months to years, much of the patient’s lifestyle and function goes unmonitored as they are at home with their partner or alone and without contact with professional providers.

Infrequent data collection relies on the ability of patients to accurately retrieve relevant details about their lives since the last checkup, which is inherently inaccurate or incomplete due to the challenges of self-report and recall.

Thus, there is a critical need in clinical trials for more frequent, accurate, and complete patient monitoring especially in communities that are currently underserved.

To meet this need, Life Analytics is furthering the development of an at-home monitoring platform, called Life Analytics Monitoring Platform (LAMP). LAMP is based off of the NIH and VA funded Collaborative Aging Research using Technology (CART) initiative system.

CART is an end-to-end (hardware and software) platform, which provides high-frequency monitoring of geriatric disease progression by measuring real-world data, thus providing a digital remote assessment model to the academic research community.

The CART system was built by, and has been further developed by, our research team in the Oregon Center for Aging and Technology (ORCATECH). Through these efforts a highly functional generalizable infrastructure for support and deployment of these systems for academic research has been established.

To date, the ORCATECH/CART platform has been installed in more than 1000 homes across North America and is currently collecting and transmitting data back to ORCATECH servers for analysis.

Additionally, the LA team has shown through publication that high-frequency in-home monitoring data allows clinical studies to be appropriately powered with fewer patients. Therefore, this platform has the high potential to change the way that clinical trials are conducted – if such a system can be broadly disseminated.

This FastTrack will assist with the critical research and development required to improve the existing ORCATECH/CART platform into the commercialized LAMP platform through the following aims:

SA 1 (Phase I): Migrate ORCATECH/CART system to secure and scalable cloud operability.

SA 2 (Phase II): Optimization of LAMP for data transfer, storage, and analysis.

SA 3 (Phase II): Demonstrate LAMP usability with alpha-testing with a third party, off-site location.

Life Analytics

NOT APPLICABLE

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Redwood City, California 940624146 United States

Single Zip Code

Administrative Supplements to Promote Diversity in Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed) (PA-21-345)

Amendment Since initial award the End Date has been extended from 07/31/22 to 11/30/24 and the total obligations have increased 582% from $453,828 to $3,094,239.