Request for Proposal: Clinical Trials for Frontotemporal Degeneration
The Alzheimer's Drug Discovery Foundation (ADDF) and The Association for Frontotemporal Degeneration (AFTD) have launched the Treat Frontotemporal Degeneration (FTD) Fund to support clinical trials testing novel or repurposed drugs for FTD and related disorders (bvFTD, PPA, PSP, CBD, FTD/ALS). The Treat FTD Fund will build on recent successes of both foundations in early-stage drug discovery and biomarker development and leverages new ongoing efforts under development by AFTD such as the recently launched FTD Disorders Registry and a $5M FTD Biomarker Initiative. Running clinical trials in FTD patients will help investigators learn how best to target this unique patient population and will employ advances in biomarkers as they develop. Through this partnership, ADDF and AFTD propose to invest $10 million dollars over 10 years to fund at least 5 innovative clinical trials subject to review by an appointed Joint Steering Committee.
Average Duration: 1-3 years
Average Award: $500,000-$2,000,000
The population targeted by the clinical trial proposed should broadly include both genetic and sporadic forms of FTD and related disorders (bvFTD, PPA, PSP, CBD, FTD/ALS). The rationale for the mechanism of action of the drug/therapy for the specific FTD patient population proposed must be included in the application.
This RFP is agnostic to drug target, open to both symptomatic and disease modifying approaches and includes both novel and repurposed therapies. Behavioral and social interventions as well as lifestyle modifications will not be considered.
The RFP will support clinical proof-of-concept studies and pilot proof-of-mechanism clinical trials utilizing pharmacodynamic-based outcome measures in a patient population. Studies designed to solely test safety in healthy volunteers will not be considered, however Phase 0/Phase 1 studies in healthy volunteers that assess pharmacodynamics outcome measures relevant to FTD will be accepted for review. Innovative clinical trial design is encouraged as is inclusion of exploratory endpoints and/or novel biomarkers.
Leveraging of existing resources, clinical coordination centers/networks, and patient registries are highly encouraged.
Relevant resources include:
- Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
- Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects (LEFFTDS)
- Genetic Frontotemporal Dementia Initiative (GENFI)
- Alzheimer's Disease Cooperative Study (ADCS)
- Alzheimer's Disease Centers (ADC)
- The FTD Disorders Registry
Applications should include a clear plan for data sharing and/or making available the results of the trial to the public.
Leveraging other sources of funding or other ongoing trials is encouraged. Partnerships/co-funding with industry or other foundations is acceptable.
Application Submission Guidelines
We are no longer accepting applications for this RFP.
For science- or finance-related inquiries, please contact:
Diana Shineman, PhD, Senior Director, Scientific Affairs, ADDF
Nadine Tatton, PhD, Scientific Director, AFTD
For application inquiries, please contact:
Heather Moore, Grants and Contracts Manager, ADDF