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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 7R42AG069629-02
Agency Tracking Number: R42AG069629
Amount: $1,500,000.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PAR18-326
Timeline
Solicitation Year: 2018
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2025-06-30
Small Business Information
80 BROAD ST
New York, NY 10004-3333
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 ERIC LEVEN
 (917) 239-7362
 eric.leven@riproad.com
Business Contact
 ERIC LEVEN
Phone: (917) 239-7362
Email: eric.leven@riproad.com
Research Institution
 BRIGHAM AND WOMEN'S HOSPITAL
 
75 FRANCIS STREET
BOSTON, MA 02115-6110
United States

 Domestic Nonprofit Research Organization
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.

* Information listed above is at the time of submission. *

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