Promising Results for New Dementia with Lewy Bodies Treatment in Phase 2 Trial

A potential breakthrough in the treatment of dementia with Lewy bodies (DLB) has emerged from a recent Phase 2 clinical trial conducted by Cognition Therapeutics Inc. The company's experimental drug, CT1812, has shown promising results in addressing multiple aspects of this devastating neurodegenerative disorder, offering hope to the estimated 1.4 million Americans affected by DLB.

The SHIMMER study, which involved 130 adults, evaluated the safety and efficacy of CT1812, an orally delivered small molecule oligomer antagonist. Participants received either a placebo or one of two doses of CT1812 (100 mg or 300 mg) daily for six months. The trial met its primary endpoint of safety and tolerability, with patients treated with CT1812 experiencing improvements in behavioral, functional, cognitive, and movement measures compared to those receiving the placebo.

Notably, the study reported an 82% slowing in the total neuropsychiatric inventory, with significant reductions in anxiety, hallucinations, and delusions among those treated with CT1812. The drug also demonstrated a marked reduction in caregiver distress, suggesting a positive impact on the daily lives of both patients and their caregivers. Cognitive measures showed a slowing of decline across all three assessed areas, including a remarkable 91% reduction in fluctuations of attention.

These results are particularly significant given the current lack of approved treatments specifically for DLB, which is known for its rapid onset and severe impact on patients' quality of life. DLB is characterized by a quick decline in thinking and reasoning abilities, independent movement, and can cause uncontrollable changes in alertness, recurring hallucinations, sleep disruptions, tremors, and slow movement.

Dr. Anthony Caggiano, Cognition's chief medical officer and head of R&D, expressed enthusiasm about the results, stating that they exceeded expectations and support the broad potential of CT1812 across neurodegenerative disorders. The company plans to present detailed data at the International Lewy Body Dementia Conference in January 2025 and will review the findings with the FDA in an end-of-phase 2 meeting.

The SHIMMER study builds on the success of Cognition's previous Phase 2 SHINE study, which examined CT1812's effects on Alzheimer's disease. That study showed a 95% slowing of cognitive decline in individuals with a key Alzheimer's biomarker, further bolstering confidence in CT1812's potential to address multiple neurodegenerative conditions.

Lisa Ricciardi, Cognition's president and CEO, highlighted the significance of these findings, especially for DLB patients who currently have few therapeutic options. The company is now poised to advance CT1812 to late-stage clinical trials, with the ultimate goal of providing a once-daily pill to treat these debilitating neurodegenerative conditions.

The development of CT1812 represents a potential paradigm shift in the treatment of DLB and possibly other neurodegenerative disorders. If successful in later-stage trials and approved for use, this drug could significantly improve the quality of life for millions of patients and their caregivers, while potentially reducing the enormous economic burden associated with these conditions. As research progresses, the medical community and those affected by DLB will be watching closely, hoping that this promising treatment will soon become a reality in the fight against neurodegenerative diseases.