Cognition Therapeutics completes enrollment in Phase 2 SHINE study

Cognition Therapeutics announced that the last participant was randomized in the Phase 2 SHINE study of CT1812, the company’s lead candidate for the treatment of age-related neurodegenerative diseases of the CNS and retina. A total of 153 adults with mild-to-moderate Alzheimer’s disease were randomized to receive either placebo or oral doses of CT1812. Endpoints include safety, change in cognitive function, as measured by ADAS-Cog 11 and biomarker evidence of disease modification. Top-line results are expected in mid 2024 after the last participants have completed six months of treatment. “Results of the SHINE trial will provide important information on safety, tolerability and cognitive effects of CT1812 in people with mild-to-moderate Alzheimer’s disease, and these results will inform our plans for Phase 3 development,” Lisa Ricciardi, president and CEO of Cognition Therapeutics stated. “Completing enrollment in the trial ahead of our 2023 target allows us to bring proof-of-concept results sooner and provides savings to our company. We couldn’t have accomplished this without the support of the study participants and caregivers as well as our investigators and collaborators at the National Institute on Aging. We look forward to seeing the full study results in mid 2024.” An evaluation of the first 24 SHINE participants showed that those treated with CT1812 experienced a slowing of cognitive decline as measured by a three-point difference on the ADAS-Cog 11 scale compared to placebo. Overall, CT1812 was well tolerated and adverse events were balanced across treatment groups, consistent with the safety profile observed in previous clinical trials.