Funding for Innovative Clinical Trials for Frontotemporal Degeneration
UPCOMING DEADLINES
Must be received by 5:00 pm ET on the deadline date.
Letter of Intent
November 9, 2018
Invited Full Proposal
February 15, 2019
Average Duration
1–3 years with potential for follow-on funding
Average Award
$500,000-$2,000,000. Leveraging other sources of funding is encouraged.
Eligibility
Funding is open to researchers and clinicians in the U.S. and worldwide working in:
- Academic medical centers and universities or nonprofits. Industry partnerships are strongly encouraged.
- Biotechnology companies that demonstrate a clear need for non-profit funding. Funding is provided through mission-related investments (MRIs) that require return on investment based upon scientific and/or business milestones. Existing companies and new spinouts are both eligible.
Introduction
Launched in 2016, the Treat FTD Fund is a joint effort by the Alzheimer's Drug Discovery Foundation (ADDF) and the Association for Frontotemporal Degeneration (AFTD) to support clinical development of novel or repurposed drugs for FTD disorders. Running clinical trials in FTD patients will enable investigators to identify optimal approaches to targeting this unique patient population. In addition, trials supported by the Treat FTD Fund will complement efforts such as the FTD Biomarkers Initiative and the Accelerating Drug Discovery for FTD program by employing emergent advances in biomarker development and preclinical research.
Funding Priorities
Patient Population: The targeted population should include both genetic and sporadic forms of any FTD disorder, including behavioral variant FTD, primary progressive aphasia, corticobasal syndrome, progressive supranuclear palsy, and FTD/ALS. A clear description of the rationale for the mechanism of action in the targeted population must be included in the application.
Therapeutic Focus: Roughly 70% of FTD disorders occur sporadically. As in Alzheimer's and other neurodegenerative diseases, a variety of mechanisms, like inflammation, proteostasis, or epigenetics, become dysfunctional with age and can contribute to disease pathogenesis. While gene therapy approaches for the genetic causes of FTD disorders are of interest, we encourage applications that target some of the underlying mechanisms that may contribute to the sporadic forms of the disease. This RFP is agnostic to target and open to symptomatic and disease-modifying approaches. Both novel and repurposed therapies are encouraged.
Behavioral and social interventions, as well as lifestyle modifications, will not be considered.
Clinical Design: The RFP will support clinical proof-of-concept and pilot proof-of-mechanism studies. Phase 0/1 studies in healthy volunteers assessing pharmacodynamic outcomes will also be accepted for review. Innovative clinical trial designs and exploratory endpoints are encouraged. Specifically, outcome measures that apply to heterogeneous FTD populations (e.g. markers of pathology due to various causes) should be included in the trial design. Multidomain biomarkers that define grouping should also be considered.
RESOURCES
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
REQUIREMENTS
Applications should include:
- Confirmation of drug supply
- IRB-ready clinical trial protocol
- Explicit plan for data sharing and/or making available the results publicly available
Applications will be confidentially reviewed by a Joint Steering Committee appointed by the ADDF and AFTD. Applications from biotechnology companies will also be reviewed by ADDF's external Business Advisory Board.
APPLICATION SUBMISSIONS
Review the Application Instructions for steps on applying.
ADDF FUNDING PORTAL
For program-related inquiries, please contact:
Lauren Friedman, PhD, Director, Scientific Affairs
lfriedman@alzdiscovery.org
Nadine Tatton, PhD, Scientific Director, AFTD
ntatton@theaftd.org
For application submission inquiries, please contact:
Mission Related Investments Team
grants@alzdiscovery.org