Clinical Trial Results - CT1812 demonstrated strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies (DLB) in the exploratory Phase 2 SHIMMER study [1] - The study met its primary endpoint of safety and tolerability, with CT1812-treated patients showing improvement in behavioral, functional, cognitive, and movement measures compared to placebo [2] - There was an 82% slowing in the total neuropsychiatric inventory (NPI), with significant reductions in anxiety, hallucinations, and delusions in the CT1812-treated arms [2] - Participants treated with CT1812 experienced a 91% slowing in the decline of attention fluctuations compared to placebo [2] Study Design and Details - The SHIMMER Phase 2 study enrolled 130 patients with mild-to-moderate DLB, randomized to receive one of two oral doses of CT1812 or placebo daily for six months [2] - The study is supported by a $30 million grant from the National Institute on Aging of the National Institutes of Health (NIH) [8] - The study is being conducted at over 30 sites in the United States, many of which are Lewy Body Dementia Association (LBDA) centers of excellence [8] Future Plans and Expectations - Cognition Therapeutics plans to advance CT1812 into late-stage trials based on the positive results from the SHIMMER study [1] - The company will present detailed data at the International Lewy Body Dementia Conference (ILBDC) in January 2025 [2] - Cognition Therapeutics will review the topline efficacy and safety findings with the FDA in an end-of-Phase 2 meeting [3] About CT1812 - CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex [10] - CT1812 is currently being investigated in clinical programs for Alzheimer’s disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD) [12] About Dementia with Lewy Bodies (DLB) - DLB is the second most common cause of dementia, affecting an estimated 1.4 million Americans [6] - The disease is caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies within brain neurons [6] - DLB disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems, leading to symptoms such as hallucinations, delusions, and movement disorders [6]
Cognition Therapeutics Announces Positive Results in Phase 2 Study of CT1812 in Dementia with Lewy Bodies