National Alzheimer’s Coordinating Center (NACC) & Gates Ventures Alzheimer’s Disease and Related Dementias (AD/ADRD) Digital Biomarker Pilot Program
Funding will be dispersed by NACC and will support:
- Partners: Provisioning digital instruments*
- ADRCs: Data collection with innovative digital instruments*
* Instruments can be from a variety of sources and offered in kind
Additional Gates funding will be provided to NACC to support the integration of this date into the NACC Data Platform and sharing it with AD/ADRD researchers through the Data Fron Door.
About the Digital Biomarker Pilot Funding Program
A key focus of this award program is to accelerate innovative digital biomarker collection and sharing across the ADRC Program and beyond to advance AD/ADRD research and discovery and leverage technology to capture more data with less burden for participants and ADRCs.
The selection committee will choose one to three pilot projects and award between $250,000 to $ 1,000,000 (direct costs, 15% indirect cap) for one to two-year digital pilot projects. Award amounts will be based on the stage and scope of the pilot projects proposed. Funding will be provided for pilot projects that leverage technology to enable richer and more objective data collection with less burden for participants and ADRCs and that advance the development and validation of digital biomarkers.
Data Sharing Requirements:
All data generated or used in each pilot project must be made accessible to the research community through the National Alzheimer's Coordinating Center (NACC) Data Platform.
Please note: Pilot projects and their partnering companies are expected to share raw digital data files with NACC.
- Add research value and increase accuracy and/or objectivity of measures
- Reduce burden: projects must demonstrate how they will reduce burden on patients and/or providers and medical center staff
- Expand and address diversity
- Involve multiple ADRCs
- Demonstrate scalability
- Be amenable to open science experiments that include broad data sharing (such as data challenges) down the line
- Funded projects, including for-profit companies, must agree to broad, raw, data sharing.
- Sleep
- Movement and/or Phone gyroscope measures
- Fall detection
- Mood State
- Speech
- Video
- Language
- Eye tracking
- Digitized UDS (Uniform Data Set) and non-UDS
- Diet
- Driving
- Keystrokes
- Wearables devices (e.g. smart watch)
- Single-Sensors
- Multi-sensor
- Mobile/tablet apps
- Smart home systems
- Virtual and augmented reality platforms
- Desktop/web apps
- Deep machine learning-AI-driven Algorithms
- Single Digital Modality Processing Software
- Multi-Digital Modality Processing Software
- Large Language Models
Timeline
- October 19, 2023: RFA Announced and Applications period opens
- January 19, 2024: Deadline for applications
- March 2024: Committee selects one to three winners and funding is awarded via NACC
Potential for follow-up support
- Promising digital pilot projects may be scaled to the full ADRC program and eligible for follow-on funding via NACC's U24 renewal.
- Funded Data Challenge using data collected from the pilots selected for funding.
- SBIR/STTR
How to Apply
Before Getting Started
1. Carefully review the RFA linked here
Application deadline: January 19, 2024
2. Review the mission statement, application restrictions and review policies, and funding policies below
- Mission Statement
- The mission of the National Alzheimer's Coordinating Center (NACC) and Gates Ventures Alzheimer's Disease and Related Dementias (AD/ADRD) Digital Biomarker Pilot (DBP) Awards is to accelerate innovative digital data collection and sharing across the Alzheimer Disease Research Center (ADRC) Program to accelerate Alzheimer's Disease and Related Dementias (AD/ADRD) research and discovery.
- The NACC and Gates Ventures AD/ADRD DBP Awards are seeking to fulfill this mission by providing funding for pilot projects that leverage technology to enable richer data collection with less burden for participants and ADRCs and that advance the development and validation of digital biomarkers. As a public charity, the DBP Awards funding must be used specifically for an approved scientific project that advances this stated mission.
- Application submission restrictions
- Any application not meeting the criteria described above will not be reviewed.
- No person involved in the review of applications may be part of a team submitting an application.
- Page Limits: 1-page project overview, 6-page research strategy (references are not included in this page limit)
- Format requirements: 12-pt minimum font size, margins no smaller than 0.5-inch, PDF format.
- No appendices will be accepted
- Application review process policies
- All applications will be reviewed by the selection committee.
- All pilot project proposals will be evaluated by the selection committee on scientific and technical merit, level of innovation, and investigator, and organizational capabilities and alignment with the goals of the RFA.
- Funding mechanism
- Pilot projects receiving funding will have a subcontract that is awarded through NACC to the partnering ADRCs on the project.
- Allowable and unallowable costs
- This funding may be provided for approved personnel costs, supplies (e.g., consumables, chemicals, animals), small non-durable equipment up to $2,500 per item, consultants, and participant costs related to the collection of data.
- This funding may not be used for cost of living, capital equipment, equipment service contracts, publication costs, or travel (unless pre-approved under special circumstances).
- Up to 15% of additional funding will be provided for indirect costs/overhead.
3. Submit your application
Please review the following application instructions and details below:
- Application instructions
After reviewing the detailed instructions below, please navigate to the REDCap application form to submit your pilot proposal.
This application form will allow you to submit the following:
Application information, includes:
- Project Title or Primary Institution
- Principle Investigators
- Key Personnel
- ADRC Collaborators
- IRB approval status
- Full proposal (in PDF format only)
- Supplemental materials (in PDF format only)
- Full Proposal Details
Formatting Requirements:
- All six proposal body sections should be compiled into a single PDF and uploaded where indicated in the application form.
- Project Overview should not exceed 1 page of written text.
- Sub-sections
2a-2gshould not exceed 6 pages of written text. - Embed figures in the text.
- Use 12pt. font and 0.5-inch margins.
The Proposal Body should include all six sections as detailed here.
- Supplemental Materials
All of the following materials are optional.
If submitting supplemental materials, compile all the materials into a single PDF and upload as "Supplemental Materials."
These materials can include:
- Quotes from vendors or contract research organizations (CROs)
- IRB-ready clinical protocols
4. Review Process
Proposals will be reviewed by the selection committee after all applications have been received on the due date, January 19, 2024. Applicants can expect to hear back on their application status within 1-2 months after the due date.
Proposal Body Details
The Proposal Body should include the following six sections:
- Project overview (1 page limit)
Provide a brief overview of the pilot proposal. Describe what problem this proposed technology will solve. Describe how this proposal will meet the criteria of expanding the collection of richer data with less burden for participants and ADRC staff.
- Project description (6 page limit)
The project description is the central part of the proposal and should contain the eight sub-sections listed below (indicate each sub-section by number in the proposal).
Background and Rationale
- Provide the biological rationale that links the candidate digital measure(s) to disease pathophysiology.
- Provide the biological rationale that links the candidate biomarker(s) to disease pathophysiology.
- Discuss the novelty of the proposed approach and its leading context of use (CoU).
- It is recommended to focus on one CoU, however, if multiple CoU are proposed, please describe additional biomarker categories here and ensure study design will support these additional categories.
Supporting Data
- Provide relevant supporting data.
- Include data that demonstrates how the candidate biomarker(s) is connected to the disease process.
- Provide data for the analytical method such as sensitivity, specificity, accuracy, parallelism, precision, sample stability, and other characteristics
Project Plan and Objectives
- Objectives: List specific aims and milestones with clearly defined go/no-go decision points for advancement of the project.
- Timeline: Use the Alzheimer’s Disease Drug Discovery Diagnostic Accelerator Project Plan Template (.xlsx) to provide a schedule for the completion of the proposed milestones/deliverables for each quarter of the year for each year of funding.
- Discuss critical next steps and/or experiments needed to advance the program to attract additional funding/licensing.
- Outline strategies for commercial scale-up, manufacturing, possible cross-platform compatibility, and regulatory approval, including the timeline for FDA submissions and milestones.
Experimental Design and Methods
- Describe sample collection methods, storage, stability, and extraction procedures.
- Provide details for each analytical method proposed and the measurement methodology.
- Include possible strategies if issues arise and any plans for the development of combined measures that may provide greater validity than an individual measure.
- Include the sourcing of all components of the analytical methods proposed.
- Provide a statistical analysis plan. Include a power analysis to justify the number of participants or samples per group.
- For validation studies, describe the strategies for maximizing reproducibility, including standard operating procedures for pre-analytical, analytical, and post-analytical stages.
- Please describe your regulatory and commercialization strategies.
Description of Investigative Team and Resources
- Describe the investigative team and explain how specific expertise of each member will contribute to completing the study objectives.
- Where internal expertise is not available, include a description of external partners (e.g. consultants, contract research organizations (CROs) that will help to execute the experimental work.
- Discuss the inclusion of any consultants with assay development expertise that were involved in the design of preclinical or clinical studies or the development of the commercialization plan.
- If applicable, discuss relationships with commercial diagnostics platform companies or plans to partner. Summarize the materials, technologies, and/or expertise provided by these collaborators.
Intellectual Property
- Provide information on existing IP and stage of prosecution.
- If no IP currently exists, describe the projected plan to generate IP; note if you expect the project to generate new IP.
- Indicate any freedom to operate issues.
Other Support
- List other financial support, awarded and pending, and include grant title, principal investigator, percent effort of investigator, granting agency, amount, and projected funding period.
- Indicate any overlap between the aims or investigator effort from other funding with the proposed work.
References
- References do not count towards the 6-page limit.
- Budget and Justification (no page limit)
Please complete and provide the following forms in the full proposal PDF:
- PHS398 Form: Complete the template PDF (download here) or Word version (download here). Download instructions here.
- Budget and Justification: Complete the template and provide a brief justification for each line item. Download the template here. NOTE: You will also be asked to submit this as a CSV file in a separate location in the application.
Proposals must outline how they will spend $250K to $1M in direct costs. Additional funding will be provided for indirect costs (up to 15%)
- Proposals do not need to provide budget details for NACC to ingest and share data.
- Please review permissible costs listed in the “Before Getting Started” section above.
- Biographical Information (no page limit)
- Include a NIH biosketch for each of the key personnel listed on this project.
- For instructions, please visit: https://grants.nih.gov/grants/forms/biosketch.htm
- Study Population Worksheet (no page limit)
- Complete the Study Population Worksheet. Download the template here.
- If using specimens from an existing cohort, a letter of support from the PI of the study is required.
- Letters of Support (no page limit)
Letters of support from ADRC’s should be included as part of your proposal.
Contact Us
Partner Information
About the ADRC Program
The National Institute on Aging (NIA) funds 33 Alzheimer's Disease Research Centers (ADRCs) at major medical institutions across the United States. Researchers at these Centers are working to translate research advances into improved diagnosis and care for people with Alzheimer's disease, as well as working to find a treatment or way to prevent Alzheimer's and other types of dementia. In addition, NIA funds four Exploratory ADRCs that are designed to expand and diversify research and education opportunities to new areas of the country, new populations, and new areas of science and approaches to research.
About NACC
The National Alzheimer's Coordinating Center (NACC) functions as the centralized data repository, and collaboration and communication hub for the National Institute of Aging's (NIA's) Alzheimer's Disease and Research Centers (ADRC) Program, which currently includes 33 centers and 4 exploratory centers across the United States.
The National Alzheimer's Coordinating Center was established in 1999 by the National Institute on Aging/NIH to facilitate collaborative research. Using data collected from NIA-funded Alzheimer's Disease Research Centers (ADRCs) across the United States, NACC has developed and maintains a large relational database of standardized clinical and neuropathological research data. In partnership with the Alzheimer's Disease Genetics Consortium (ADGC), the National Centralized Repository for Alzheimer's Disease and Related Disorders (NCRAD), and the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), NACC provides a valuable resource for both exploratory and explanatory Alzheimer's disease research. NACC data are freely available to all researchers.
About Gates Ventures
Gates Ventures is the private Executive office of Microsoft co-founder and philanthropist Bill Gates and was founded 2008 in Kirkland, Washington, United States. It comprises his personal staff, a think tank on problems of health and global development, and a technology investment portfolio.
