UPCOMING DEADLINES

Must be received by 5:00 pm ET on the deadline date.

Letter of Intent
January 17, 2020

Invited Full Proposal
February 7, 2020

Letter of Intent
April 10, 2020

Invited Full Proposal
May 8, 2020

Letter of Intent
July 10, 2020

Invited Full Proposal
August 7, 2020

Letter of Intent
October 9, 2020

Invited Full Proposal
November 6, 2020

 
 

FUNDING OPPORTUNITY DESCRIPTION

The goal of this RFP is to increase the number of innovative pharmacologic interventions tested in clinical studies for Alzheimer’s disease and related dementias. This includes novel, repurposed, and repositioned drugs as well as natural products.

Specifically, the PACT RFP supports:

1. Early-stage human clinical trials including:

  • Phase 1 single ascending dose and multiple ascending dose studies
  • Biomarker-based proof-of-concept or proof-of-mechanism studies. These studies can validate novel molecular targets in humans and de-risk novel therapeutic approaches earlier in clinical development by assessing the potential efficacy of therapeutic interventions using pharmacodynamic outcomes.

2. Regulatory studies including:

  • Non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture required for investigational new drug (IND) and clinical trial authorization (CTA) preclinical packages. Funding is available for preparation of traditional and exploratory IND applications.
  • Long-term toxicology studies to enable longer-term dosing in phase 2 trials
  • GMP manufacturing and testing of clinical grade drug required to move into phase 2 or phase 3 trials

The ADDF is interested in small molecules and biologics (e.g. antibodies, peptides, gene therapies).

Current target areas of interest include:

  • Epigenetics
  • Inflammation
  • Mitochondria & metabolic function
  • Neuroprotection
  • Proteostasis
  • Synaptic activity and neurotransmitters
  • Vascular function
  • Other aging target (e.g. senescent cells)
  • Other novel targets or pathways that are supported by compelling evidence demonstrating a rational biological connection to the disease process

Please note: This RFP does not support anti-amyloid approaches (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) or cholinesterase inhibitors.

 

AWARD INFORMATION

Average Award:
Up to $3,000,000 based on stage and scope of research. 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 recruitment

Average Duration:
Multi-year
Potential for follow-on funding

Allowable cost:
Only direct costs are allowed. Please review our Funding Policy

 

ELIGIBILITY

Funding is open to researchers and clinicians worldwide at:

  • Academic medical centers and universities or nonprofits. Industry partnerships are strongly 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 both eligible.
 

FUNDING PRIORITIES

The ADDF prioritizes novel drug candidates with composition of matter intellectual property (IP) and repurposed and repositioned drugs with strategies to develop novel IP. Applications should include compelling preclinical packages with robust target engagement and efficacy data in relevant animal model(s) and demonstrated blood-brain barrier permeability for CNS targeted therapies.

For clinical trials, we prioritize applications that:

  • Include data on dose optimization for the intended route of administration and treatment duration for the drug candidate
  • Provide strong rationale for the proposed clinical population based on the drug candidate’s mode of action
  • Outline strategies for successful recruitment, retention and protocol adherence, with evidence of prior success for recruitment of the proposed number and population
  • Carefully select biomarkers that will measure target engagement and intermediate readouts that are proximal to clinical outcomes
  • Demonstrate evidence of safety from earlier clinical studies, where available, and plans to address remaining safety concerns in the proposed clinical design
  • For repurposing studies, a supplier that will provide sufficient quantities of the drug or compound to complete the study aims has been identified
 

EVALUATION

All proposals will be evaluated for:

1. Rational biological connection of the target to the disease pathophysiology

  • Is this a novel target? How is the target more compelling than other related targets that have been tested for the disease?
  • 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?
  • If the molecular target is unknown, the strength of the evidence for the mode of action and its link to disease pathophysiology will be evaluated. The applicant should summarize the existing evidence in the proposal.
 

2. Strength of the preliminary data

  • Are there compelling preclinical and clinical data to justify the proposed study?
  • Does the application include data supporting target engagement?
 

3. Feasibility, research design, and methodology

  • Are the intervention modalities (arms, allocation, dosing frequency, and route) well-defined and justified?
  • Are outcomes/endpoints that measure target engagement, tolerance and responsiveness included? The inclusion of direct and indirect measures of target engagement are strongly recommended where possible.
  • Have the outcome measures been validated to detect changes in the defined clinical population?
  • Is the study appropriately powered to detect changes in the primary outcome in the defined clinical population?
  • Are the procedures for data collection, management and analysis well-defined? For multi-site clinical trials, have the methods for standardization of procedures been described and justified?
 

4. Justification for proposed the clinical population

  • Is the clinical population (age, co-morbidities, genotype) well-defined and justified?
  • Is the stage of disease appropriate for the drug candidate’s mode of action?
  • Is the clinical population enriched to exhibit the appropriate phenotype for the proposed study (e.g. positive amyloid PET for an anti-amyloid therapy)?
 

5. Investigative team, organizational capabilities, and project budget

  • Do the PI(s) and collaborators have the appropriate experience to design and execute the project? Note: Clinical trials often require resources beyond those available at a single organization and collaboration with other investigators and contract research organizations and consultants are encouraged.
  • Do the investigators have complementary and integrated expertise?
  • Is the budget appropriate for the proposed aims?

All clinical trials receiving ADDF funding must register and submit results for “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information website.

 

APPLICATION SUBMISSIONS

Review the Application Instructions for steps on applying.

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The ADDF considers its application process an iterative one and would be happy to talk to you about your drug development program.

For program-related inquiries, please contact:
Alessio Travaglia, PhD, Scientific Program Officer
atravaglia@alzdiscovery.org

For application submission inquiries, please contact:
Grants and Mission-Related Investments Team
grants@alzdiscovery.org