Cognition Therapeutics, Inc. announced that the first clinical trial site has been activated and can begin recruiting participants for the 540-patient Phase 2 START study of CT1812 in adults with early Alzheimer’s disease. The University of Kentucky Sanders-Brown Center on Aging (SBCoA) is the first of approximately 50 sites in North America that has been activated by the Alzheimer's Clinical Trials Consortium (ACTC). The ACTC, founded in 2018 with funding from the National Institute on Aging (NIA), part of the National Institutes of Health, is one of the NIA’s largest public-private partnerships.

The randomized placebo-controlled START trial is being conducted at approximately 50 sites in North America including over 30 premier academic institutions that are part of the ACTC network. An estimated 540 adults with early Alzheimer’s disease (MMSE 20-30) who have elevated beta amyloid (Aß) will be randomized to receive once-daily oral CT1812 or placebo for 18 months. CT1812 is an investigational oral, small molecule designed to bind to a receptor on synapses and prevent the toxic effects of soluble Aß oligomers on neurons.

To date, CT1812 has been studied in over 200 healthy volunteers and adults with Alzheimer's disease or dementia with Lewy bodies (DLB). The tolerability profile of CT1812 has been consistent throughout clinical development. Most adverse events have been mild to moderate in severity with no deaths and no treatment-related serious adverse events reported.

We have observed mild and transient elevations of liver enzymes without any other indications of liver injury, which returned to normal after cessation of treatment.