Foundation / Corporation
Alzheimer's Drug Discovery Foundation (ADDF)
11/09/18 5:00 PM EST Receipt
Grants to USA, Canada, and International researchers, postdoctoral fellows, and clinicians based at nonprofits, universities, academic medical centers, and biotechnology companies for clinical studies of therapies for Alzheimer’s and related dementias. LOIs are due April 13. The purpose of this program is to support innovative drug treatments tested in humans.
The true test for new therapies is their performance in human clinical studies. While the final phases of clinical testing can cost hundreds of millions of dollars, human proof-of-mechanism and proof-of-concept trials in patients can garner interest from investors and pharmaceutical companies. However, funding to bridge the gap from preclinical candidate selection to phase 2a trials for Alzheimer's disease and related dementias is limited. Since 1998, the Alzheimer's Drug Discovery Foundation (ADDF) has provided over $29 million in funding for early stage clinical trials of drugs to treat Alzheimer's disease and related dementias. And to help propel novel drugs into the clinic, the ADDF has also provided over $6.5 million to support the final preclinical studies required by regulatory agencies for the initiation of clinical research studies.
The goal of the Program to Accelerate Clinical Trials (PACT) RFP is to increase the number of innovative treatments tested in humans for Alzheimer's disease and related dementias. This program will fund (1) clinical trials through Phase 2a of novel drug candidates, including small molecules and biologics (antibodies, oligonucleotides, peptides, gene therapies, cell therapies); (2) proof-of-concept biomarker-based trials in patients for repurposed/repositioned drugs*; (3) regulatory studies for investigational new drug (IND)/clinical trial application (CTA) preclinical packages that are required before testing novel drugs in human subjects.
*Repurposed refers to existing drugs that are approved for other diseases and conditions and repositioned refers to existing drugs that have entered clinical trials for other indications and have not yet been approved.
Drug targets: Proposed molecular targets will be evaluated based on the strength of available evidence that links the target to the disease and demonstrates that modulating its biological activity will improve symptoms or modify disease progression.
Targets will be assessed based on the following criteria:
-Is there human genetic evidence linking the target to the disease?
-Is the target expressed in disease-relevant regions of the brain (or where applicable, in the periphery) in humans and/or animal models?
-Are there changes in target mRNA/protein expression or activity in human disease specimens, and do they correlate with disease severity and cognitive functions?
-Does genetic and/or pharmacological manipulation of the target in disease-relevant in vitro (e.g., primary cultured neurons/glia or cells derived from patient iPSCs) or in vivo models alter disease phenotypes?
-Are there direct measures of target engagement that can be used experimentally and in humans?
-How is the target more compelling than other related targets that have been tested for the disease?
Current target areas of interest include, but are not limited to:
-Mitochondria & metabolic function
-Synaptic activity & neurotransmitters
Clinical trials: The majority of PACT funding will support early-stage clinical trials in humans including phase 0 micro- or sub-therapeutic-dosing studies, phase 1 safety and pharmacology testing, and phase 2a biomarker-based, proof-of-concept studies. This RFP supports novel, repurposed/repositioned, and natural product approaches.
NEW IN 2018—Experimental medicine: As part of a new initiative to de-risk novel therapeutic approaches with human data earlier in clinical development, the ADDF will support exploratory studies that demonstrate proof-of-mechanism or proof-of-concept with novel or repurposed/repositioned drugs in patients. In line with the experimental medicine approaches developed by the National Institute of Mental Health, the goal is to validate novel molecular targets in humans and to assess therapeutic interventions in treating Alzheimer's and related dementias using pharmacodynamic outcomes.
Regulatory studies: The PACT RFP provides support for IND-enabling pharmacology and toxicology studies and scale-up, pre-formulation, and GMP manufacture. Funding is available to support the preparation of traditional IND and exploratory IND (eIND) applications. ADDF funding is also available for long-term toxicology studies and GMP manufacture required to move into phase 2 or phase 3 trials.
Priority is given to programs with:
-Blood-brain barrier permeability (for CNS-targeted therapies) and dose optimization for the intended route of administration and treatment duration for the drug candidate
-Target engagement and efficacy data in relevant animal model(s) with the drug candidate
-Strong data packages demonstrating selectivity, microsomal stability, aqueous solubility, plasma protein binding, and CYP profiling of drug candidate
-Clinical biomarkers that will directly measure target engagement and can monitor treatment effects in human subjects
-Intellectual property (for novel therapeutic approaches)
-Strong rationale for the proposed clinical population
-Strategies for successful recruitment and retention, with evidence of prior success for recruitment of the proposed population and number (for clinical trial proposals only)
GrantWatch ID#: 172502
Grants are up to $3 million based on stage and scope of research.
Average grant duration varies (multi-year) with potential for follow-on funding.
Funding is open to researchers, clinicians, and postdoctoral fellows in the U.S. and worldwide working in:
-Academic medical centers and universities or nonprofits
-Biotechnology companies that demonstrate a clear need for nonprofit 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.
This RFP does not support anti-amyloid approaches (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) and cholinesterase inhibitors.
For studies requiring additional support beyond ADDF funding, co-funding from other funding agencies or investors is encouraged.
Materials must be received by 5:00 PM EST on the deadline date.
-Letter of Intent: January 19, 2018
-Invited Full Proposal: February 9, 2018
-Letter of Intent: April 13, 2018
-Invited Full Proposal: May 11, 2018
-Letter of Intent: July 13, 2018
-Invited Full Proposal: August 10, 2018
-Letter of Intent: October 12, 2018
-Invited Full Proposal: November 9, 2018
Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.
For program-related inquiries, please contact:
Lauren Friedman, PhD, Acting Director, Scientific Affairs
For application submission inquiries, please contact:
Grants and Mission-Related Investments Team
Alzheimer's Drug Discovery Foundation
57 West 57th Street, Suite 904
New York, NY 10019
USA: Alabama; Alaska; Arizona; Arkansas; California; Colorado; Connecticut; Delaware; Florida; Georgia; Hawaii; Idaho; Illinois; Indiana; Iowa; Kansas; Kentucky; Louisiana; Maine; Maryland; Massachusetts; Michigan; Minnesota; Mississippi; Missouri; Montana; Nebraska; Nevada; New Hampshire; New Jersey; New Mexico; New York City; New York; North Carolina; North Dakota; Ohio; Oklahoma; Oregon; Pennsylvania; Rhode Island; South Carolina; South Dakota; Tennessee; Texas; Utah; Vermont; Virginia; Washington, DC; Washington; West Virginia; Wisconsin; Wyoming
USA Territories: American Samoa (USA) Guam (USA) Puerto Rico (USA) Virgin Islands (USA) Northern Mariana Islands (USA)
USA Compact Free Associations: The Federated States of Micronesia (USA) Marshall Islands (USA) Republic of Palau (USA)
Canada: Alberta British Columbia Manitoba New Brunswick Newfoundland and Labrador Northwest Territories Nova Scotia Nunavut Ontario Prince Edward Island Quebec Saskatchewan Yukon
International country outside of the USA, Israel and Canada.