The Treat FTD Fund
AFTD, in partnership with the Alzheimer’s Drug Discovery Foundation (ADDF) launched the Treat FTD Fund in 2016 to address the unique challenges of developing effective treatments for FTD disorders. Early-stage clinical trials supported through the Treat FTD Fund will build on our growing understanding of the biological mechanisms underlying FTD and will complement other AFTD grant programs such as the FTD Biomarkers Initiative and the Accelerating Drug Discovery for FTD program by leveraging progress in biomarker development and preclinical research.
Program Goals: 2020–2021 Funding Cycle
The December 2020 RFP for the Treat FTD Fund seeks to support clinical trials of drugs or devices with:
- Biological mechanisms that have a sound scientific rationale for FTD
- Suitable clinical trial designs, which may include basket trials, adaptive study designs or other novel approaches
- Biomarkers that can indicate target engagement and/or downstream pharmacologic effects
- Biomarker endpoints that can provide a deeper understanding of the drug mechanism and disease progression
Guidelines for Proposed Trials
Genetic or sporadic forms of any FTD disorder:
- Behavioral variant FTD
- Primary progressive aphasia
- Corticobasal syndrome
- Progressive supranuclear palsy
- ALS with FTD
As well as
- Asymptomatic individuals at risk for developing FTD
- Healthy individuals (for phase 1 studies)
- Disease-modifying or symptomatic treatments
- Experimental and repurposed drugs, including small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides (ASOs), and others
- Non-pharmacologic interventions, such as devices will also be considered
Drugs should have completed or be in the process of completing IND-enabling studies at the time of application.
Phase 1 or phase 2 studies, including:
- Single ascending dose (SAD) and multiple ascending dose (MAD) studies
- Exploratory phase 1b or phase 2a trials designed to assess pharmacologic effects with shorter treatment durations and fewer patients than a traditional phase 2 study
- Smaller studies that address one critical question or can further de-risk a clinical program
- Other studies that fit the goals of the fund
The inclusion of biomarkers that can measure pharmacokinetic/pharmacodynamic relationships and evidence of target engagement is strongly encouraged.
Leveraging of existing resources, clinical coordination centers/networks, and patient registries are highly encouraged.
Relevant resources include:
- ARTFL-LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
- Genetic Frontotemporal Dementia Initiative (GENFI)
- FTD Prevention Initiative
- The FTD Disorders Registry
Up to $2,000,000 based on stage and scope of the trial. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged.
Who can apply?
Researchers and clinicians worldwide at:
- Academic medical centers, universities or non-profits. Industry partnerships are encouraged.
- Biotechnology companies. Funding is provided through mission-related investments that require return on investment based upon scientific and/or business milestones. Existing companies and new startups are eligible
Timeline: 2021 Awards
- December 2020: RFP posted
- February 5, 2021: LOIs due
- March 19, 2021: Invited full proposals due
Applications should include:
- Confirmation of drug supply
- IRB-ready clinical trial protocol
- Explicit plan for data sharing and/or making trial results publicly available
Applications are reviewed by a Joint Steering Committee appointed by AFTD and ADDF. Applications from biotechnology companies will also be reviewed by ADDF’s Business Advisory Board.
Click here to view the RFP and access the application portal.
For program-related inquiries, please contact:
- Meriel Owen, PhD, Assistant Director, ADDF
Email: [email protected]
- Debra Niehoff, PhD, Research Manager, AFTD
Phone: 267-758-8654 / Email: [email protected]
For application submission inquiries, please contact:
- Grants and Mission-Related Investments Team
E-mail: [email protected]