The START study is supported by a grant of approximately $81 million for 5 years from the National Institutes of Health’s (NIH) National Institute on Aging (NIA) to accelerate development of new therapies for Alzheimer’s disease.
“The START study and ACTC represent some of the many ways that NIA funds research into novel therapeutics for treating Alzheimer's and related dementias,” stated Laurie Ryan, Ph.D., an NIA clinical research program official.
“We appreciate the continued support of the NIA, which has been an important partner in our work to develop CT1812. Our lead drug candidate is a potentially disease-modifying oral therapeutic for the treatment of Alzheimer's disease and other neurodegenerative conditions,” added Cognition president and CEO, Lisa Ricciardi. “With the NIA's funding, we have been able to complete a series of preclinical and clinical trials, thus advancing our understanding of CT1812 and the role of the sigma-2 (s-2) receptor in Alzheimer’s disease. We look forward to recruiting patients for the START study with our collaboration partners at the ACTC.”
“ACTC aims to accelerate Alzheimer’s drug development, working with academic and industry partners,” said Paul Aisen, M.D., professor of neurology at the University of Southern California and director of the Alzheimer's Therapeutic Research Institute. “The START study is an important component of ACTC efforts. Having an authorized protocol for the START study is a critical step in preparing to open clinical sites for the trial by mid-2023.”
NEW YORK, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that it has cleared the U.S. Food and Drug Administration comment period and may now proceed with the 540-patient Phase 2 START study of CT1812 in adults with mild cognitive impairment or early Alzheimer’s disease. This randomized placebo-controlled trial will be conducted at approximately 50-to-60 sites in North America including those premier institutions in the Alzheimer's Clinical Trials Consortium (ACTC). CT1812 is an investigational oral small molecule that binds to a receptor on synapses and is designed to prevent the toxic effects of soluble beta amyloid (Aß) oligomers on neurons, which drive the progression of neurodegenerative diseases such as Alzheimer’s disease.
“The initial clinical results observed with CT1812 are encouraging and we look forward to advancing it into the START trial to evaluate its effects in a larger study in people with early Alzheimer’s disease,” said Christopher H. van Dyck, M.D., director of the Yale Alzheimer's Disease Research Center and primary investigator of the START study. “We envision a future with multiple treatment options, to be used alone or in combination according to evidence, to achieve the greatest slowing of Alzheimer's disease progression.”
