Cognition Therapeutics Inc. (NASDAQ: CGTX) has announced encouraging topline results from its Phase 2 SHIMMER study for CT1812, an experimental oral medication aimed at treating dementia with Lewy bodies (DLB). The clinical-stage company, focused on developing drugs for neurodegenerative disorders, reported that CT1812 demonstrated strong therapeutic responses across multiple measures in DLB patients.
DLB affects approximately 1.4 million people in the United States and is considered the costliest form of dementia. It is characterized by rapid onset of symptoms, including decline in thinking and reasoning, impaired independent movement, and uncontrollable changes in alertness. Currently, there are no approved cures for DLB, with existing treatments focusing solely on symptom management.
The SHIMMER study, which enrolled 130 adults, evaluated the safety and efficacy of CT1812 over a six-month period. Participants received either a placebo or one of two doses of CT1812 (100 mg or 300 mg) once daily. The study met its primary endpoint of safety and tolerability, with patients treated with CT1812 showing improvements in behavioral, functional, cognitive, and movement measures compared to the placebo group.
Notably, the study reported an 82% slowing in the total neuropsychiatric inventory (NPI), with significant reductions in anxiety, hallucinations, and delusions among patients receiving CT1812. The treatment also led to a marked reduction in caregiver distress, suggesting a positive impact on patients’ daily lives. Cognitive measures showed a slowing of decline across all three assessed areas, including a 91% reduction in fluctuations of attention for those treated with CT1812.
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.
The SHIMMER study received significant support, including a grant award of approximately $30 million from the National Institute on Aging of the National Institutes of Health (NIH). It was conducted in collaboration with the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA).
These positive results follow Cognition Therapeutics’ earlier success with CT1812 in a Phase 2 SHINE study for Alzheimer’s disease, where the drug demonstrated a 95% slowing of cognitive decline in patients with a key Alzheimer’s biomarker. The combined results from SHIMMER and SHINE studies have bolstered confidence in CT1812’s clinical activity and its potential to address multiple neurodegenerative conditions.
Lisa Ricciardi, Cognition’s president and CEO, emphasized the significance of these findings, particularly for DLB patients who currently have limited therapeutic options. The company is now looking forward to advancing CT1812 to late-stage clinical trials, with the goal of developing a once-daily pill to treat these devastating neurodegenerative conditions.
As neurodegenerative disorders continue to pose significant challenges to global health, the development of CT1812 represents a potentially important advancement in the field. If successful in further trials, this drug could offer new hope to millions of patients and their caregivers who are affected by dementia with Lewy bodies and related conditions.
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