NIH – Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional)

Alzheimer’s disease (AD) is one of the most common age-associated diseases, and because of the aging of populations worldwide this disorder is predicted to reach epidemic proportions, with an enormous human and economic burden, by the year 2050. To avert this public health crisis, effective therapies that prevent AD, slow its progression or treat its cognitive and behavioral symptoms are urgently needed. The recent advances in understanding the neurobiology of AD offer unprecedented opportunities to discover new treatments for AD. However, despite these scientific advances, the development of effective AD therapies has been challenging, as is evidenced by the recent string of disappointing clinical trials. Consequently, the failure to translate scientific advances into new therapies, coupled with increased R&D expenditures, has largely dampened enthusiasm for AD drug development, leaving little hope for millions of AD patients and their families. To catalyze drug development for AD, the NIA is reissuing, with this Funding Opportunity Announcement (FOA),  the Alzheimer’s Drug Development Program (ADDP), which offers researchers funding for drug development activities that can be conducted in their own laboratories, in collaboration with contract research organizations (CROs) that specialize in various drug development activities including medicinal chemistry, pharmacokinetics (PK), Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET), formulations development, efficacy in animal models, chemical synthesis under Good Manufacturing Practices (GMP), Investigational New Drug (IND) enabling safety-toxicology and initial Phase I clinical testing.

Scope

The overarching goal of the ADDP is the development of a broad range of novel therapeutic agents for AD including small molecules, natural products, and biologics against validated targets. The program is not designed to support research on basic mechanisms of disease, mechanisms of drug action, development of biomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies or activities such as high throughput screening.

To maintain portfolio diversity this program does not support projects aimed at anti-amyloid therapies.

Projects can enter the ADDP either at the Early Stage to optimize the agent’s potency, drug-like properties, specificity, pharmacological properties, ADMET properties and undergo Investigational New Drug (IND)-enabling safety toxicology, or at the Late Stage, to advance development candidates through (IND)-enabling toxicology studies and initial Phase I clinical testing.

Deadlines:  standard dates and standard AIDS dates apply (letters of intent are due 30 days prior to the deadline)

URL:  https://grants.nih.gov/grants/guide/pa-files/PAR-18-820.html