SBIR/STTR Research Award

The Assessment of Smart Phone Everyday Tasks (ASSET): A new IADL test for early AD

Award identifier a8cb651b303a52787e412009f7c0755da556609c55cee0a7f30293e66b54cd04Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$326,862

Program and phase

STTR · Phase I

Award year

2020

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
ADK Group, LLC
Proposal award date
2020-09-01
Contract end date
2021-05-31
UEI
W52FNK8RZ9K4
Solicitation number
PAR18-326
Topic code
NIA

Research abstract

Project SummaryImpairment in instrumental activities of daily living (IADL) is a hallmark of Alzheimer’s disease (AD) dementia and a major source of patient and caregiver burden. Similarly to cognitive changes in AD, subtle difficulties in IADL may begin even before the stage of amnestic mild cognitive impairment (MCI). Recently, greater emphasis has been placed on preclinical AD, which consists of individuals with minimal or no symptoms but biological marker evidence of AD pathology. As secondary prevention trials in preclinical AD are underway and the Food and Drug Administration (FDA) is providing new guidance for early-stage AD clinical trial outcome measures, it is imperative that we develop new ecologically valid instruments to be able to track the emergence of subtle yet clinically meaningful alterations in IADL. Older individuals are increasingly required to interact via the telephone, computer, and most recently smartphone, to perform essential IADL, such as refilling prescriptions, communicating with healthcare providers, and performing financial transactions. Most IADL tests do not use everyday technology and are insufficiently validated. The goal of this project is to complete the development of, optimize, and validate a novel performance-based IADL instrument that uses a smartphone to assess healthcare-related daily activities, the Assessment of Smartphone Everyday Tasks (ASSET).For Phase 1, during Year 1 of the award, we will first develop 5 alternate versions of ASSET. We will then recruit 20 cognitively normal young adults (YN), 20 cognitively normal older adults (CN), and 20 amnestic mild cognitive impairment (MCI) participants at a single site, the Center for Alzheimer Research and Treatment (CART) at Brigham and Women’s Hospital (BWH). Those 60 participants will undergo cognitive testing and ASSET in the research clinic. The 60 participants will then undergo short-interval (2 weeks) test-retest reliability of the 6 versions of ASSET (current version and 5 new alternate versions) remotely/at-home.For Phase 2, during Years 2 and 3 of the award, CART will serve as a coordinating center for 10 Alzheimer’s Disease Research Center (ADRC) sites, each of which will recruit 20 CN, 20 older adults with subjective cognitive decline, and 10 MCI participants for a total of 500 participants. Those participants will undergo the Uniform Data Set (UDS) neuropsychological testing battery as part of their ADRC annual visits, as well as the smartphone app tasks, ASSET, and a subjective questionnaire at baseline and 1 year later, and in between remotely at home, they will also perform ASSET on a monthly basis. Finally, AD pathology biomarker data (amyloid positron emission tomography or cerebrospinal fluid abeta positive/negative) available from other studies at the ADRC performance sites will be analyzed in about half of participants.Project NarrativeThe field is moving toward finding more sensitive clinical measures for early diagnosis and tracking of subtle changes over time that are associated with AD biomarkers but are easy and inexpensive to administer by primary care physicians, who are on the frontlines of the medical battle. Developing more sensitive, ecologically valid performance-based IADL tests like ASSET is vital to the goal of improving the tracking of individuals through the tipping point between preclinical AD and prodromal AD. ASSET has been designed to tap the high-level healthcare-related tasks that challenge seniors in daily life and are important to them, to serve as a clinically meaningful outcome measure for preclinical and prodromal AD trials, and to be easy and quick to administer remotely/at-home, using real-life devices.

Technology keywords

Not reported

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Agency intelligence

Department of Health and Human Services

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