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Cognition Therapeutics (CGTX) announced topline results from the exploratory Phase 2 ‘SHIMMER’ study demonstrating CT1812 produced strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies. Designed as a signal-finding study, the SHIMMER Phase 2 study enrolled 130 patients with mild-to-moderate DLB who were randomized to receive one of two oral doses of CT1812 or placebo daily for six months. Results indicate the study met its primary endpoint of safety and tolerability, with data showing that DLB patients treated with CT1812 for six months experienced improvement in behavioral, functional, cognitive and movement measures compared to placebo. Importantly, there was an 82% slowing in the total neuropsychiatric inventory with particularly strong reduction in anxiety, hallucinations, and delusions in the CT1812 treated arms. In addition, there was a marked reduction in caregiver distress, which suggests a positive impact on the day-to-day lives of those receiving the drug. Participants treated with CT1812 experienced a slowing of decline across all three cognitive measures compared to placebo, including fluctuations in attention which declined by 91%. Detailed data will be presented at the International Lewy Body Dementia Conference in January 2025. “These topline results exceeded our expectations and support the broad potential of CT1812 across neurodegenerative disorders,” stated Anthony Caggiano, CMO and head of R&D. “Analysis of CT1812’s activity in DLB will continue as additional data become available. We look forward to reporting these findings at future medical meetings and reviewing them with the FDA in an end-of-Phase 2 meeting.”
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