A Phase 2 clinical trial, known as SHIMMER, has shown that CT1812, a small-molecule oligomeric antagonist, significantly improves outcomes in patients with Lewy body dementia (DLB). The results, which will be presented at the upcoming International Lewy Body Dementia Conference (ILBDC) in Amsterdam, show improvements in behavior, function, cognition, and movement, as well as a reduction in neuropsychiatric symptoms compared to those who received a placebo.
The SHIMMER trial randomly assigned 130 patients with mild to moderate Lewy body dementia (DLB) to receive one of two oral doses of the experimental drug CT1812 or a placebo daily for six months. The results showed that patients treated with CT1812 experienced a 91% decrease in attention fluctuations and an 82% slowdown in the total neuropsychiatric inventory, accompanied by a significant reduction in symptoms of anxiety, hallucinations, and other forms of delirium.
CT1812 is a small-molecule oligomeric antagonist that primarily acts by blocking the formation and accumulation of beta-amyloid (Aβ) oligomers in the brain. Beta-amyloid oligomers are considered one of the main pathogenic factors in Alzheimer's disease and Lewy body dementia (DLB).
By blocking the formation of these oligomers, CT1812 aims to reduce neuroinflammatory inflammation and protect nerve cells from damage, thereby improving cognitive and behavioral functions in patients with DLB.
The study met its primary endpoint of safety and tolerability. Additionally, a significant reduction in caregiver distress was observed, suggesting that the treatment could have a lasting positive impact on the quality of life of both patients and their caregivers.
"These preliminary results have exceeded our expectations and support the broad potential of CT1812 in neurodegenerative disorders," said Anthony Caggiano, Chief Medical Officer and Head of Research and Development at Cognition Therapeutics. "We look forward to presenting these results at upcoming medical meetings and discussing them with the FDA in a late Phase 2 meeting."
James E. Galvin, Director of the Comprehensive Center for Brain Health at the University of Miami and Principal Investigator on the SHIMMER study, emphasized: "The results of this Phase 2 exploratory study have shown that CT1812 may have a significant and positive impact on patients with DLB on multiple measures of cognitive, behavioral, motor, and functional performance. Lewy body dementia (DLB) is a complex disease characterized by a wide range of symptoms. The results of this study indicate that CT1812 shows promising therapeutic effects on patients with DLB, offering potential benefit for both patients and their caregivers."
Lisa Ricciardi, President and CEO of Cognition Therapeutics, stated: "With the results of the SHIMMER and SHINE studies, we are confident in the clinical activity of CT1812, as it has demonstrated broad neurological and neuroprotective activity in DLB and Alzheimer's disease."
"People suffering from these diseases, particularly DLB, have few therapeutic options that lead to a cascade of painful symptoms for the individual and their caregivers," she added. "We are eager to continue the development of CT1812 in late-stage clinical trials with the hope of providing a daily pill that can treat these devastating neurodegenerative conditions."