Cognition Therapeutics reports promising Phase 2 results for CT1812 in dementia with Lewy bodies

Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage pharmaceutical company focused on neurodegenerative disorder treatment, has reported highly encouraging Phase 2 trial results for CT1812, a small-molecule treatment for dementia with Lewy bodies (DLB). The exploratory SHIMMER study demonstrated that CT1812, administered orally, significantly improved behavioural, functional, cognitive, and movement outcomes in patients with mild-to-moderate DLB.

Promising Outcomes for CT1812 Treatment Results

The SHIMMER Phase 2 trial revealed that CT1812 achieved meaningful therapeutic benefits, with patients showing a dramatic 82% slowing in neuropsychiatric inventory scores compared to placebo. Symptoms such as anxiety, hallucinations, and delusions, which are hallmark challenges in dementia with Lewy bodies, saw substantial reductions. Moreover, patients experienced a 91% improvement in fluctuations in attention, a core measure of cognitive decline in DLB. These outcomes reflect not just clinical improvements but also a marked reduction in caregiver burden, positively impacting day-to-day life for both patients and their families.

Dr. James E. Galvin, director of the Comprehensive Center for Brain Health at the University of Miami and a principal investigator of the trial, noted that these CT1812 treatment results highlight the potential for this drug to address the diverse and debilitating symptoms associated with Lewy body dementia. He described the findings as both exciting and promising, underscoring the broad potential impact of this neurodegenerative disorder treatment.

Rigorous Study Design to Support Results

The SHIMMER trial, designed as a double-blind, placebo-controlled Phase 2 trial, enrolled 130 adults with mild-to-moderate dementia with Lewy bodies. Participants were randomised to receive one of two CT1812 doses or a placebo over six months, with rigorous assessments conducted using validated tools such as the Neuropsychiatric Inventory (NPI) and the Montreal Cognitive Assessment (MoCA). These metrics were complemented by the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), enabling researchers to capture improvements in movement-related symptoms common in DLB.

This clinical trial, supported by a $30 million grant from the National Institute on Aging, was conducted at over 30 U.S.-based research sites, many of which are recognised as centres of excellence in the treatment of Lewy body dementia. The strong collaboration between Cognition Therapeutics, the University of Miami, and the Lewy Body Dementia Association has further elevated the significance of this study.

Understanding the Mechanism of CT1812

CT1812 works by targeting the sigma-2 receptor complex, a crucial cellular regulator disrupted in neurodegenerative disorders such as dementia with Lewy bodies and Alzheimer’s disease. By selectively binding to these receptors, CT1812 blocks toxic oligomers like α-synuclein and Aβ, which drive cognitive decline and disease progression. This approach not only protects synaptic function but also slows the cascading effects of neurodegeneration, offering a potentially transformative neurodegenerative disorder treatment.

Advancing Toward Late-Stage Development

Following the robust findings of the SHIMMER Phase 2 trial, Cognition Therapeutics is now planning late-stage clinical trials to further evaluate CT1812’s efficacy. The results suggest that this once-daily treatment could become a game-changer for individuals with dementia with Lewy bodies, who currently face limited therapeutic options.

Dr. Anthony Caggiano, chief medical officer and head of research and development at Cognition Therapeutics, expressed confidence in the broad applicability of CT1812. He emphasised that the CT1812 treatment results exceeded expectations and validated the drug’s neuroprotective potential, not only for Lewy body dementia but also for other neurodegenerative conditions like Alzheimer’s disease.

Lisa Ricciardi, the company’s CEO, echoed this sentiment, highlighting the urgent need for innovative solutions to address the devastating symptoms of dementia with Lewy bodies. She reaffirmed Cognition Therapeutics’ commitment to improving the lives of both patients and caregivers through cutting-edge neurodegenerative disorder treatment.

Future Presentations and Insights

The detailed findings from the SHIMMER study will be presented at the International Lewy Body Dementia Conference (ILBDC) in January 2025. Cognition Therapeutics has also scheduled a conference call for December 18 at 8 a.m. ET to discuss the clinical trial results in depth. These events are expected to provide further insights into the potential of CT1812 as a breakthrough treatment for dementia with Lewy bodies and other neurodegenerative disorders.

Expanding CT1812 Research

Beyond the SHIMMER trial, Cognition Therapeutics is actively recruiting participants for additional studies of CT1812. The START study focuses on adults with early Alzheimer’s disease, while the MAGNIFY study evaluates its impact on geographic atrophy (GA) due to dry age-related macular degeneration. These trials underscore the company’s commitment to exploring CT1812’s potential as a versatile and effective neurodegenerative disorder treatment.