Program to Accelerate Clinical Trials (PACT)

Grants to USA, Canada, and International clinicians and researchers based at nonprofits, for-profits, IHEs, and medical centers for research related to Alzheimer’s disease and dementia. Applicants must submit an LOI prior to applying. Funding is intended to support IND-enabling studies 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 models of action related to the biology of aging and other emerging therapeutic areas for dementia.The RFP supports:Early-stage human clinical trials:Phase 0 micro- or sub-therapeutic dosing studiesPhase 1 trials in healthy subjectsBiomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effectsRegulatory studies:Non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture required for an 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 trialsGMP manufacture and testing of clinical-grade drug required to move into phase 2 or phase 3 trialsFor clinical trial applications, if IND-enabling work is in progress, funding for clinical studies would be contingent upon an IND (or equivalent) being granted and a full review of the data package.For information about Types of Therapy, Drug Mechanism, and Modes of Action, see the URL for Full Text.