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: 2022–2023 Funding Cycle
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
- Therapeutics applicable to both sporadic and genetic forms of FTD
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
Where appropriate, proposals should include biomarkers that can measure pharmacokinetic/pharmacodynamic relationships and evidence of target engagement. Inclusion of novel, exploratory biomarkers that can provide insight into the biological effects of the intervention are encouraged. Biomarkers used for participant selection or patient stratification are also encouraged, where relevant and available.
Leveraging of existing resources, clinical coordination centers/networks, and patient registries are highly encouraged.
Relevant resources include:
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. Payment structure will be negotiated and based on milestone achievements and patient enrollment.
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: 2023 Awards
- Letter of Intent: January 27, 2023
- Invited full proposal: March 17, 2023
Applications will be reviewed confidentially by a panel of FTD experts. Applicants may expect to receive recommended revisions to their workplan or clinical trial design as part of the review process.
Click here to view the RFP and access the application portal.