The Alzheimer's Association is pleased to announce the Part the Cloud Translational Research Funding initiative to increase the research efforts in Phase I and Phase II clinical trials directed towards Alzheimer’s disease and related dementias internationally.
There is no greater healthcare need than slowing or preventing Alzheimer’s disease. The vast increase in understanding of the neurobiology of AD in recent decades, from genetic factors to amyloid accumulation, tangle formation, cellular dysfunction and synaptic failure, has led to the identification of highly promising targets for new therapies. The process of developing candidate therapies is long and complex leading to the failure of many drug development programs. The steps from target identification to the clinic includes high-throughput screening, lead optimization, establishing target engagement in vitro and in vivo, assuring central nervous system penetration, animal toxicology and finally the three phases of human testing. The full process takes many years and substantial resources, and typically involves different groups of investigators at different stages.
While many academic investigators and companies have successfully discovered candidate therapeutics, and have succeeded in the preclinical stages of development, moving into human testing can be a major stumbling block. Most government and non- government grant mechanisms support preclinical development or mid to latter clinical trials testing drug efficacy in humans, but there are few mechanisms for supporting the critical earlier human phase studies. At present, the National Institute on Aging supports AD drug development research, including basic research on target identification, animal model testing of candidate therapeutics, toxicology and proof-of-concept studies in humans. These latter human studies must be preceded by smaller, early phase studies but there are few appropriate funding mechanisms to fund the next step, Phase I trials in humans.
Deadline: March 23, 2022
Applications will be accepted from academic investigators and small companies with lead candidate therapeutic agents that require early stage testing (Phase 1 or Phase 2) prior to the larger Phase 2b or 3 efficacy studies, or with lead therapeutic agents that have already established human safety data and require a small-scale pilot Proof of Mechanism (POM) study in humans to begin proving the scientific concept in humans. This award will support Phase 1 studies or pilot small- scale Phase 2a studies for novel or repurposed potential compounds in cognitively unimpaired, mild cognitive impairment or later stages of disease, including single and multiple dose studies to establish safety, brain penetration and/or target engagement and POM in preparation for larger proof of concept trials.
Both non-profit and small for-profit agencies are eligible. Open to International Applicants. Small for-profit agencies must submit documentation of net assets and annual earnings during the letter of intent process as a part of the review process. Not-for-profit organizations must submit documentation verifying status during the letter of intent process.
We anticipate funding up to six Part the Cloud Research Awards. Each grant is limited to $800,000 (direct and indirect costs) over two or three years. Indirect costs are capped at 10 percent (rent for laboratory/office space is expected to be covered by indirect costs paid to the institution). Please note: This is for Phase 1 and/or Phase 2 human studies and must be at least 90% of the budget for costs related to conducting the clinical trial. Related studies and preliminary study, while important, do not fall under this request for applications (RFA).
