Funder: Alzheimer's Drug Discovery Foundation
Due Dates: September 15, 2025 (Letter of Intent) | November 17, 2025 (Invited Full Proposal)
Funding Amounts: Up to $5,000,000 per award, multi-year duration, milestone-based payments focused on direct costs.
Summary: Supports IND-enabling studies and early-phase clinical trials for Alzheimer's and related dementias, prioritizing novel drug mechanisms related to aging biology and combination therapies.
Description
The Alzheimer's Drug Discovery Foundation (ADDF) offers funding to accelerate drug development for Alzheimer's disease (AD) and related dementias. This opportunity supports investigational new drug (IND)-enabling studies and early-phase clinical trials (Phase 0 to 2a) that test promising pharmacological interventions and devices. The program emphasizes novel drug mechanisms connected to the biology of aging and emerging therapeutic areas for dementia.
Strategic Priorities
- Combination therapies involving two or more drugs administered together or as combination products, including:
- Co-development of multiple new investigational drugs
- A new investigational drug combined with an approved anti-amyloid monoclonal antibody
- Fixed combinations of two approved drugs
- Disease-modifying and symptomatic agents
Stage of Development Supported
- Early-stage human clinical trials:
- Phase 0 micro- or sub-therapeutic dosing studies
- Phase 1 trials in healthy subjects or patients
- Biomarker-based proof-of-concept studies (typically Phase 1b or 2a) assessing target engagement and pharmacologic effects
- IND (or international equivalent) enabling studies:
- Non-GLP and GLP pharmacology and toxicology studies
- Pre-formulation and GMP manufacture of active pharmaceutical ingredients (API) and drug products
- Preparation of traditional and exploratory IND applications
- Long-term toxicology studies for extended dosing in Phase 2 trials
- GMP manufacturing/testing to support progression to Phase 2 or 3 trials
Clinical trial funding is contingent on successful IND (or equivalent) approval if IND-enabling work is ongoing.
Types of Therapies Considered
- Novel, repurposed, and repositioned drugs
- Natural products and devices
- Therapeutic modalities including small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides, and stem cells
Non-pharmacologic interventions such as diet, meditation, and exercise are not considered.
Drug Mechanisms or Modes of Action of Interest
High priority is given to novel mechanisms related to the biology of aging and dementia, including but not limited to:
- Epigenetics
- Inflammation
- Mitochondrial and metabolic function
- Neuroprotection
- Proteostasis
- Synaptic activity and neurotransmitters
- Vascular function
- Senescent cells and other aging-related mechanisms
- Other novel mechanisms with strong biological rationale linked to disease pathophysiology
Note: Anti-amyloid approaches (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) and cholinesterase inhibitor proposals are excluded.
Due Dates
- September 15, 2025 — Letter of Intent (LOI) deadline
- November 17, 2025 — Invited Full Proposal deadline
Note: The April 21, 2025 full proposal deadline has passed.
All submissions must be received by 5:00 pm ET on the deadline date.
Funding Amount
- Awards up to $5,000,000 depending on the stage and scope of research
- Multi-year funding duration
- Payments are milestone-based and contingent on recruitment and scientific/business milestones
- Only direct costs are allowable
- Co-funding from other agencies or investors is encouraged for larger studies
Eligibility
- Open worldwide to researchers and clinicians at:
- Academic medical centers, universities, and nonprofits (industry partnerships encouraged)
- Biotechnology companies, including startups and established firms
- Funding is provided as mission-related investments requiring return on investment based on milestones
- Both individual investigators and small businesses are eligible
Application Process
- Applicants must submit a Letter of Intent by the LOI deadline to be considered for invitation to submit a full proposal.
- Full proposals are by invitation only following LOI review.
- Applications are submitted through the ADDF online portal (LOG IN or CREATE ACCOUNT).
- Applicants are encouraged to contact ADDF for initial feedback on proposed projects.
Expectations and Evaluation Criteria
Strong proposals typically include:
- Clear rationale and compelling evidence for the novel mechanism or mode of action targeted
- Human genetic evidence linking the target to AD or related dementias
- Expression of the target in disease-relevant brain regions or peripheral tissues
- Correlation of target expression/activity with disease severity and cognitive function
- Evidence from genetic or pharmacological manipulation in relevant in vitro or in vivo models showing impact on disease phenotypes
- Preliminary data including:
- Preclinical efficacy in relevant animal models
- Blood-brain barrier penetration data for CNS therapies
- Pharmacokinetic/pharmacodynamic (PK/PD) data for dose optimization
- Safety data and plans to address remaining safety concerns
- Justification of clinical population selection, including clinical subtype, disease stage, genetics (e.g., ApoE status), and neuropathology (e.g., amyloid positivity)
- Recruitment feasibility for the target patient population
- Biomarker-based proof-of-concept study design addressing safety, target engagement, pharmacologic effects, and disease-related outcomes
- Inclusion of clinical assessments aligned with disease stage and mechanism of action
- Early involvement of biostatisticians for study design and sample size calculations
- Collaborative investigative teams including external investigators, contract research organizations, and consultants as needed
All clinical trials funded must register and submit results on ClinicalTrials.gov.
Additional Information
- Anti-amyloid and cholinesterase inhibitor drug proposals are not eligible.
- Funding supports milestone-based payments focused on direct costs.
- ADDF follows a venture philanthropy model, supporting high-risk, high-reward projects.
- Co-funding and partnerships with other funders or investors are encouraged.
- Detailed application instructions and funding policies are available on the ADDF website.
External Links
Contact Information