SBIR-STTR Award

Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials
Award last edited on: 1/31/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$2,903,796
Award Phase
2
Solicitation Topic Code
866
Principal Investigator
Lawrence (Larry) Frye

Company Information

Life Analytics Inc

659 Southdale Way
Woodside, CA 94062
   (650) 544-5994
   N/A
   N/A
Location: Single
Congr. District: 16
County: San Mateo

Phase I

Contract Number: 1R44AG076067-01
Start Date: 2/1/2022    Completed: 7/31/2022
Phase I year
2022
Phase I Amount
$453,828
Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) adverselyimpact our large and growing aging population. An estimated 5.8 million American's 65 years and older aresuffering from AD, with that number projected to hit 13.8 million by 2050. Aging African American and Latinxpopulations are particularly hard-hit by AD/ADRD, as are rural communities due to lack of access to clinicaltrials and medical care. A broad range of symptoms are associated with these diseases and each patient'sprogression is unique and clinically quite variable. During a clinical trial, when longitudinal studies areconducted over months to years, much of the patient's lifestyle and function goes unmonitored as they are athome with their partner or alone and without contact with professional providers. Infrequent data collectionrelies 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 acritical need in clinical trials for more frequent, accurate, and complete patient monitoring especially incommunities that are currently underserved. To meet this need, Life Analytics is furthering the development ofan at-home monitoring platform, called Life Analytics Monitoring Platform (LAMP). LAMP is based off of theNIH and VA funded Collaborative Aging Research Using Technology (CART) initiative system. CART is anend-to-end (hardware and software) platform, which provides high-frequency monitoring of geriatric diseaseprogression by measuring real-world data, thus providing a digital remote assessment model to the academicresearch community. The CART system was built by, and has been further developed by, our research team inthe Oregon Center for Aging and Technology (ORCATECH). Through these efforts a highly functionalgeneralizable infrastructure for support and deployment of these systems for academic research has beenestablished. To date, the ORCATECH/CART platform has been installed in more than 1000 homes acrossNorth 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 allowsclinical studies to be appropriately powered with fewer patients. Therefore, this platform has the high potentialto change the way that clinical trials are conducted - if such a system can broadly disseminated. This Fastrackwill assist with the critical research and development required to improve the existing ORCATECH/CARTplatform into the commercialized LAMP platform through the following Aims: SA 1 (Phase I): MigrateORCATECH/CART system to secure and scalable cloud operability. SA 2 (Phase II): Optimization of LAMP fordata transfer, storage, and analysis. SA 3 (Phase II): Demonstrate LAMP usability with Alpha-testing with athird party, off-site location.

Public Health Relevance Statement:


Project narrative:
Alzheimer's disease and Alzheimer's disease-related dementia (AD/ADRD) are characterized by severe dementia that interferes with daily tasks, reduced memorization abilities, poor behavior, and inability to think clearly and afflicts nearly 6 million Americans 65 years and older. Clinical trials addressing AD/ADRD require large patient cohorts and are notorious for failures with over 400 unsuccessful attempts last decade. In this proposal, we further develop a non-invasive, at-home AD/ADRD patient monitoring platform that will provide continuous and quantitative measurements of health related biomarkers which in turn will improve the efficiency of clinical trials by providing high-frequency data to inform go/no-go decisions.

Project Terms:

Phase II

Contract Number: 4R44AG076067-02
Start Date: 2/1/2022    Completed: 11/30/2024
Phase II year
2023
(last award dollars: 2024)
Phase II Amount
$2,449,968

Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) adverselyimpact our large and growing aging population. An estimated 5.8 million American's 65 years and older aresuffering from AD, with that number projected to hit 13.8 million by 2050. Aging African American and Latinxpopulations are particularly hard-hit by AD/ADRD, as are rural communities due to lack of access to clinicaltrials and medical care. A broad range of symptoms are associated with these diseases and each patient'sprogression is unique and clinically quite variable. During a clinical trial, when longitudinal studies areconducted over months to years, much of the patient's lifestyle and function goes unmonitored as they are athome with their partner or alone and without contact with professional providers. Infrequent data collectionrelies 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 acritical need in clinical trials for more frequent, accurate, and complete patient monitoring especially incommunities that are currently underserved. To meet this need, Life Analytics is furthering the development ofan at-home monitoring platform, called Life Analytics Monitoring Platform (LAMP). LAMP is based off of theNIH and VA funded Collaborative Aging Research Using Technology (CART) initiative system. CART is anend-to-end (hardware and software) platform, which provides high-frequency monitoring of geriatric diseaseprogression by measuring real-world data, thus providing a digital remote assessment model to the academicresearch community. The CART system was built by, and has been further developed by, our research team inthe Oregon Center for Aging and Technology (ORCATECH). Through these efforts a highly functionalgeneralizable infrastructure for support and deployment of these systems for academic research has beenestablished. To date, the ORCATECH/CART platform has been installed in more than 1000 homes acrossNorth 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 allowsclinical studies to be appropriately powered with fewer patients. Therefore, this platform has the high potentialto change the way that clinical trials are conducted - if such a system can broadly disseminated. This Fastrackwill assist with the critical research and development required to improve the existing ORCATECH/CARTplatform into the commercialized LAMP platform through the following Aims: SA 1 (Phase I): MigrateORCATECH/CART system to secure and scalable cloud operability. SA 2 (Phase II): Optimization of LAMP fordata transfer, storage, and analysis. SA 3 (Phase II): Demonstrate LAMP usability with Alpha-testing with athird party, off-site location.

Public Health Relevance Statement:


Project narrative:
Alzheimer's disease and Alzheimer's disease-related dementia (AD/ADRD) are characterized by severe dementia that interferes with daily tasks, reduced memorization abilities, poor behavior, and inability to think clearly and afflicts nearly 6 million Americans 65 years and older. Clinical trials addressing AD/ADRD require large patient cohorts and are notorious for failures with over 400 unsuccessful attempts last decade. In this proposal, we further develop a non-invasive, at-home AD/ADRD patient monitoring platform that will provide continuous and quantitative measurements of health related biomarkers which in turn will improve the efficiency of clinical trials by providing high-frequency data to inform go/no-go decisions.

Project Terms: