SBIR/STTR Research Award
The Assessment of Smart Phone Everyday Tasks (ASSET): A new IADL test for early AD
Award amount
$326,862Program and phase
STTR · Phase IAward year
2020Award 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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