Drug Development RFP Grant

The Drug Development RFP by the Alzheimer's Drug Discovery Foundation invites innovative proposals for early-phase clinical trials targeting Alzheimer's disease and related dementias. This funding prioritizes diverse drug mechanisms, excluding amyloid-targeted and cholinesterase inhibitors. Eligible applicants include academic institutions and biotechnology firms, with funding up to $5 million. The focus is on novel therapies and comprehensive analyses of mechanisms of action, encouraging partnerships to enhance research outcomes.

The Drug Development RFP supports investigational new drug (IND)-enabling studies (or the international equivalent) and early-phase clinical trials that test promising pharmacological interventions and devices for Alzheimer’s disease (AD) and related dementias. Both disease-modifying and symptomatic agents will be considered.
This funding opportunity prioritizes diverse drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia. For this reason, amyloid targeted approaches and cholinesterase inhibitor proposals will not be considered for this RFP.
Stage of development
Early-stage human clinical trials including:
Phase 0 micro- or sub-therapeutic-dosing studiesPhase 1 trials in healthy subjects or patientsBiomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effects
IND (or international equivalent) – enabling studies including:
Non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture of API and/or drug product required for regulatory packages. Funding is available for preparation of traditional and exploratory IND (or international equivalent) applicationsLong-term toxicology studies to enable longer-term dosing in phase 2 trialsGMP manufacturing and testing of API and/or drug product required to move into phase 2 or phase 3 trials
For clinical trial applications, if IND-enabling work is in progress, funding for clinical studies would be contingent upon an IND (or equivalent) successfully going into effect.
Type of therapy
Novel, repurposed and repositioned drugs, as well as natural products and devices will be considered. Therapeutic modalities of interest include small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides, and stem cells. Other non-pharmacologic interventions, such as diet, meditation, and exercise, will not be considered. A detailed landscape analysis to compare competition related to the mode or mechanism of action is strongly encouraged.
Drug mechanisms or modes of action
Novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia are considered high priority. These include, but are not limited to:
EpigeneticsInflammationMitochondrial & metabolic functionNeuroprotectionProteostasisSynaptic activity and neurotransmittersVascular functionOther mechanisms and modes of action related to the biology of aging (e.g. senescent cells)Other novel mechanisms or modes of action that are supported by compelling evidence demonstrating a rational biological connection to the disease processPlease note: Anti-amyloid approaches (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) and cholinesterase inhibitor proposals will not be considered
Award Information
Up to $5,000,000 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.
Multi-year duration and only direct costs are allowed.

Eligibility

Funding is open to researchers and clinicians worldwide at:Academic medical centers and universities or nonprofits.Biotechnology companies. Existing companies and new startups are both eligible.