This Notice of Special Interest (NOSI) is intended to promote research on the use of digital technology for early detection and monitoring of cognitive and functional decline in persons with Alzheimer’s disease (AD) and AD-related dementias (ADRD).

Background

Early diagnosis and monitoring of AD/ADRD is an unmet need and a major goal in the Department of Health and Human Services National Plan to Address Alzheimer’s Disease. There is evidence that the functional, psychological, pathological, and physiological changes underlying AD/ADRD may emerge many years prior to the clinical manifestation of cognitive symptoms, prompting this call for earlier indicators of disease risk and subclinical disease burden.

Current biomarkers for early detection of prodromal AD/ADRD (e.g., PET/MRI imaging) are costly and invasive. Digital technology the branch of scientific or engineering knowledge that deals with the creation and practical use of digital or computerized devices, methods, and systems and data produced by digital devices offer novel capabilities with great potential for earlier detection of cognitive and associated functional change. Digital signals are high-frequency, time-series data, produced by a single individual, which capture health-related aspects of daily life. Examples of digital signals range from simple measures of physical activity such as gait and geospatial location to sleep duration and quality, heart rate, pain level, language, speech, and cognition, to more complex behavior such as driving. Digital biomarkers are derived via signal processing (of high-dimensional and often noisy digital signals) and can be used to inform disease prediction and management at both the individual and population level.

This NOSI is based on expert discussions from the NIH AD and ADRD research summits and NIA workshops, including Applying Digital Technology for Early Diagnosis and Monitoring of Alzheimer’s Disease and Related Dementias (2019) and Cost-Effective Early Detection of Cognitive Decline (2017).

Objectives

The goal of this NOSI is to facilitate research on the use of digital signals and data as ‘biomarkers’ that may flag or signal early changes within individuals at risk of AD/ADRD before cognitive symptoms are evidenced by current cognitive assessment and/or brain imaging biomarkers. Promising areas of research include, but are not limited to:

1. Developing and optimizing sensors (bioengineering and design), or repurposing existing sensors, for daily activity measurement in older adults, e.g. physical activity patterns, gait, behavioral and life-space monitoring.
2. Developing new or refining existing sensors for physiological and psychological measurements, such as speech spectral analysis, blood pressure monitoring, heart rate variability, emotion regulation, and sleep pattern monitoring.
3. Validating digital markers in all stages of AD/ADRD, including prodromal, mild cognitive impairment (MCI), and dementia to enhance sensitivity and specificity for early detection of AD/ADRD.
4. Improving the accessibility of digital devices for use by individuals from diverse socioeconomic and geographical backgrounds (e.g., improving digital devices for health disparities research).
5. Developing and validating cognitive screening instruments or assessments and translating them into systems (e.g., electronic health records) for assisting with meaningful care recommendations for individuals with cognitive impairment.
6. Developing machine learning approaches for mining data from multiple sources and validating them for predicting cognitive decline.

The anticipated outcomes should be centered on cost-effective, user-friendly solutions that can be readily used in remote, urban, and peri-urban communities by persons with dementia in and around their homes and/or their residential facility. The anticipated activities performed during the award should lead to collaborations among multidisciplinary teams (e.g., software engineers, bioengineers, physicians, neuroscientists, and scientists) that have substantial potential for early identification of individuals who are at high risk for AD/ADRD, to inform prevention and disease monitoring efforts. Data and resource sharing (i.e., the tools generated from the NOSI) are required (see NIA Guidance on Sharing Data and other Resources).

Application and Submission Information

This notice applies to due dates on or after July 9, 2020 and subsequent receipt dates through November 13, 2021.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice:

• PAR-19-070 Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)
• PAR-19-071 Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

For funding consideration, applicants must include “NOT-AG-20-017” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Yuan Luo
National Institutes on Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Dana Plude
National Institutes on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Lyndon Joseph
National Institutes on Aging (NIA)
Telephone: 301-496- 6761
Email: [email protected]