Alzheimer’s Drug Discovery Foundation: Program to Accelerate Clinical Trials

The Alzheimer’s Drug Discovery Foundation welcomes Letters of Intent for its Program to Accelerate Clinical Trials (PACT).

The goal of the program is to increase the number of innovative pharmacologic interventions tested in clinical studies for Alzheimer’s disease and related dementias.

In particular, the PACT program will fund:

Early Stage Human Clinical Trials — Including phase 0 micro- or sub-therapeutic-dosing studies; phase 1 trials in healthy subjects; and biomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effects.

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; and GMP manufacturing and testing of clinical grade drug required to move into phase 2 or phase 3 trials.

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. Current target areas of interest include epigenetics, inflammation, mitochondria and metabolic function, neuroprotection, proteostasis, synaptic activity and neurotransmitters, vascular function, aging targets (e.g., senescent cells), and other novel targets or pathways that are supported by compelling evidence demonstrating a rational biological connection to the disease process.

Up to $3 million will be awarded based on stage and scope of research. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged.

The RFP is open to researchers and clinicians worldwide at academic medical centers, universities, nonprofits, and biotechnology companies. Existing companies and new spinouts are both eligible, and industry partnerships are strongly encouraged.

Letters of Intent must be received no later than February 5, 2021. Upon review, selected applicants will be invited to submit a full proposal by April 16, 2021.

For complete program guidelines and application instructions, see the Alzheimer’s Drug Discovery Foundation website.