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

Deadline: January 18, 2019

The Alzheimer’s Drug Discovery Foundation aims to increase the number of innovative pharmacologic interventions tested in clinical studies for Alzheimer’s disease and related dementias. The Program to Accelerate Clinical Trials (PACT) supports clinical trials, experimental medicine, and regulatory studies for novel drugs (small molecules and biologics including antibodies, peptides, gene therapies), repurposed drugs (existing drugs that are approved for other diseases and conditions), repositioned drugs (existing drugs that have entered clinical trials for other indications and have not yet been approved), and natural products.

Specifically, PACT will support:

Early-stage human clinical trials:

  • Phase 0 micro- or sub-therapeutic-dosing studies.
  • Phase 1 single ascending dose and multiple ascending dose studies.
  • Phase 2a 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.

Regulatory studies:

  • Non-GLP (Good Laboratory Practices) and GLP pharmacology and toxicology studies, and scale-up, pre-formulation, and Good Manufacturing Practices (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, if not completed prior to phase 1 studies.
  • GMP manufacture and testing of clinical grade drug required to move into phase 2 or phase 3 trials.

Current target drug areas of interest include, but are not limited to:

  • Neuroprotection
  • Inflammation
  • Vascular function
  • Mitochondria & metabolic function
  • Proteostasis
  • ApoE (Apolipoprotein E)
  • Epigenetics
  • Synaptic activity and neurotransmitters
  • Other aging targets (e.g., senescent cells)

Other novel targets and pathways that are supported by compelling evidence demonstrating a rational biological connection to the disease process are encouraged.

Amount: Grants of up to $5,000,000 will be awarded based on stage and scope of research.

Eligibility: 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.

Link: https://www.alzdiscovery.org/research-and-grants/funding-opportunities/pact

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