Co-funded by The ALS Association and The Association for Frontotemporal Degeneration
Opportunity Has Closed
Digital Assessment Tools for FTD and ALS Awards support the development of digital tools with broad applicability across the FTD-ALS spectrum beyond the discovery stage toward validation.
ALS and frontotemporal degeneration (FTD), once considered separate neurodegenerative diseases, are now recognized as having many commonalities at the molecular, cellular and clinical level. Experts have proposed that these disorders constitute a clinical spectrum, with some people exhibiting primarily ALS symptoms, some exhibiting primarily FTD symptoms and others exhibiting overlapping symptom profiles. This intersection is a compelling reason to prioritize the development of diagnostic tools and therapeutics applicable to both diseases to help facilitate the alignment of clinical care practices as well as drug and biomarker development.
ALS and FTD present challenges to clinical care and research. For example, the small number of potential participants in clinical trials for these rare disorders increases the probability they will be underpowered. Symptoms observed in the clinical setting may not accurately reflect behavior in the home environment, while travel to clinical sites is burdensome. Digital assessment tools have the potential to overcome these challenges. Remote monitoring methods utilizing wearable sensors or handheld devices would allow for more frequent assessments, improving power. Data collection either in the person’s home or in local clinics with a non-specialized clinical team member could increase frequency, accuracy and intraindividual reliability. Additionally, assessment in a local setting could facilitate recruitment, increase diversity and reduce travel burden.
Despite these advantages and many innovative attempts, no digital assessment tool has yet been validated for non-exploratory use in regulatory-grade clinical trials for any neurodegenerative disorder. And despite the commonalities between FTD and ALS, the fields of ALS and FTD use different assessment tools to measure clinical severity.
To drive progress in digital tool development at the intersection of ALS and FTD, The ALS Association and The Association for Frontotemporal Degeneration have launched the Digital Assessment Tools for FTD and ALS Awards. This one-time funding opportunity will support projects seeking to refine, evaluate, adapt or validate promising digital tools that have already undergone preliminary testing in humans, with a focus on aligning approaches across ALS and FTD.
To view the full request for proposals, click here.
Two types of applications will be considered:
Advancing Tool Development
These applications should clearly indicate the stage of development of the digital tool to be utilized and its relevance to FTD and ALS. Example of suitable research topics include but are not limited to:
- Adaptation or testing of a digital assessment developed for ALS in an FTD cohort or vice versa.
- Further development, verification or analytical validation of a digital assessment tool already tested in both ALS and FTD cohorts.
- Head–to-head comparison of digital assessment tools developed for ALS or FTD across both disorders.
- Evaluation or development of a digital tool from a related disease space in both ALS and FTD cohorts.
- Harmonization of digital assessment tool data across FTD and ALS clinical cohorts to enable maturation of tools applicable to the populations and clinical settings of both disorders.
Projects focused on the above topics can utilize existing data as well as data collected de novo.
Creating a Conceptual Model as a Guide for Digital Outcome Assessment Development
To strengthen long-term development of digital assessment tools, proposals to fund the development of a conceptual model that could, in turn, serve as the foundation for the creation of measurement models to quantify patient experience will be considered. The conceptual model should be inclusive of ALS and FTD, for example, for the prodromal C9orf72 mutation or FTD-ALS. All projects should adhere to FDA guidance on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, and applicants should clearly explain how their project plan will address specific recommendations within that guidance.
The following are not appropriate for this funding opportunity:
- Discovery-stage or pilot studies of a digital assessment tool not yet tested clinically.
- Projects primarily designed to develop or expand a clinical database for future algorithm or tool development.
Funding and Eligibility
Budget requests between $150,000 and $400,000 over 2 years (January 1, 2024 – December 31, 2026) will be considered depending on the stage of development and scope of the project. Grant applicants at academic or nonprofit institutions may request up to 10% of the approved budget to be allocated to indirect costs.
Investigators worldwide from academic or other nonprofit research institutions as well as for-profit organizations, such as biotechnology or digital technology companies, are eligible to apply. Other types of organizations may also be eligible. Collaborative arrangements (e.g., between academia and industry or ALS and FTD researchers) are encouraged.
Applications must include evidence of clinical or research expertise in both ALS and FTD. This expertise may be provided by one individual with dual expertise or any combination of the principal investigator (PI), co-PI, another member of the research team and outside collaborators/advisors. Postdoctoral researchers cannot apply as the lead PI but can be co-PIs on a project team.
Key Dates and Deadlines
- Submission Portal and Detailed Application Instructions Available on AFTD Website: May 26, 2023.
- Submission Deadline: July 28, 2023 by 8 p.m. ET
- Anticipated Award Decision: October 2023
- Project Start Date: January 1, 2024
More information about this funding opportunity is available on the AFTD website. You are welcome to contact AFTD to discuss your proposed project prior to submission or to get more information about eligibility, the submission process or the online portal.