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Cognition Therapeutics and the Alzheimer's Clinical Trials Consortium Begin First Clinical Site for Phase 2 START Study in Early Alzheimer's Disease

Thursday, July 06, 2023

Cognition Therapeutics, Inc. (NASDAQ: CGTX) has announced the activation of the first clinical trial site for their Phase 2 START study in early Alzheimer's disease. The study, which will evaluate the efficacy of CT1812 in adults with early Alzheimer's, is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC). The University of Kentucky Sanders-Brown Center on Aging (SBCoA) is the initial site to be activated among the approximately 50 sites planned across North America.

The ACTC, established in 2018 with funding from the National Institute on Aging (NIA), is one of the largest public-private partnerships supported by the NIA. Its aim is to facilitate academic clinical trials in Alzheimer's disease. The consortium comprises over 30 premier academic institutions, and its involvement in the START study is expected to provide crucial support to Cognition Therapeutics.

The Phase 2 START trial will be a randomized, placebo-controlled study involving around 540 adults with early Alzheimer's disease. Participants, who will have elevated beta amyloid levels, will be randomly assigned to receive either once-daily oral CT1812 or a placebo for a duration of 18 months. CT1812 is an investigational oral medication designed to target and bind to synapse receptors, aiming to mitigate the toxic effects of soluble beta amyloid oligomers on neurons.

Lisa Ricciardi, President and CEO of Cognition Therapeutics, expressed enthusiasm for the START study, emphasizing the significance of studying CT1812 in individuals with early-stage Alzheimer's disease. She acknowledged the challenges faced by small biotechnology companies in conducting trials of this nature and highlighted the support provided by the ACTC and the NIA's grant in enabling the study to move forward.

The activation of the SBCoA site represents an important milestone for the study. Dr. Paul Aisen, Professor of Neurology at the University of Southern California and Director of the Alzheimer's Therapeutic Research Institute, expressed anticipation in partnering with SBCoA and other investigators to initiate participant screening for the START study.

CT1812 has undergone previous studies involving over 200 healthy volunteers, as well as individuals with Alzheimer's disease or dementia with Lewy bodies. The tolerability profile of CT1812 has been consistent throughout clinical development, with mostly mild to moderate adverse events reported. There were no reported deaths or treatment-related serious adverse events. Transient elevations of liver enzymes were observed, but they resolved after discontinuation of treatment without any signs of liver injury.

Further information about the START study, including details for potential participants, can be found on the ClinicalTrials.gov website using the trial identifier NCT05531656.

CT1812 is an experimental oral medication designed to selectively bind to the sigma-2 (σ-2) receptor complex. This receptor complex plays a role in regulating key cellular processes that are impaired by toxic interactions with beta amyloid oligomers and other stressors. The development of CT1812 includes its evaluation in the SHINE study (NCT03507790) for mild-to-moderate Alzheimer's disease and the SHIMMER study (NCT05225415) for dementia with Lewy bodies.

The ACTC, funded by the NIA, serves as a vital infrastructure for academic clinical trials in Alzheimer's disease and related dementias. With primary clinical sites spread across the United States, the consortium aims to enhance research and advance potential treatments for Alzheimer's disease.

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