Cognition Therapeutics Reports SHINE Study Data Analysis Results at CTAD

Cognition Therapeutics, Inc., a clinical-stage company focused on developing treatments for neurodegenerative disorders, recently shared significant findings from its Phase 2 SHINE study at the Clinical Trials on Alzheimer’s Disease (CTAD) conference. The study examined the effects of CT1812, an experimental drug, on individuals with mild-to-moderate Alzheimer’s disease, particularly focusing on its impact on cognitive decline.

CT1812's performance was notably effective in participants with lower levels of plasma p-tau217, a biomarker highly associated with Alzheimer’s disease. Specifically, those treated with CT1812 showed a 95% reduction in cognitive decline as measured by ADAS-Cog 11 scores and a 108% reduction when assessed by MMSE scores. In contrast, participants in the placebo group exhibited significant cognitive decline in both measures.

Dr. Michael Woodward, who presented the data, noted that participants with low p-tau217 levels responded particularly well to CT1812. This observation aligns with previous experiences with anti-amyloid immunotherapies, which also tend to be more effective in individuals with lower p-tau levels. Dr. Woodward emphasized the substantial cognitive preservation observed in CT1812-treated patients and suggested that plasma p-tau217 could potentially serve as a predictive biomarker for the treatment’s effectiveness.

Anthony Caggiano, Chief Medical Officer and head of R&D at Cognition Therapeutics, reinforced the importance of these findings by highlighting the emerging durable effect of CT1812 over time. The company aims to confirm this effect in longer-term studies and plans to engage with the FDA to discuss Phase 3 trial approaches, specifically targeting patients with lower plasma p-tau217 levels to maximize treatment efficacy.

The SHINE study, which enrolled 153 adults with mild-to-moderate Alzheimer’s disease, was a double-blind, placebo-controlled trial. Participants were randomly assigned to receive either a placebo or one of two doses of CT1812 (100 mg or 300 mg) daily for six months. The primary endpoint was to evaluate the drug’s safety and tolerability, while the key secondary endpoint focused on cognitive performance as measured by ADAS-Cog 11 scores. Exploratory endpoints included changes in MMSE, ADAS-Cog 13, ADCS-ADL, and CGIC scores, along with subgroup analyses based on plasma p-tau217 levels.

CT1812 is an orally administered small molecule that penetrates the blood-brain barrier and selectively binds to the sigma-2 (σ-2) receptor complex. This binding displaces toxic Aβ oligomers, which are known to damage synaptic functions and contribute to cognitive impairment and Alzheimer’s disease progression. The SHINE study, supported by grants from the National Institute on Aging, is part of Cognition Therapeutics’ broader effort to develop treatments targeting the underlying mechanisms of neurodegenerative diseases.

Currently, participants are being recruited for the START study of CT1812 in early Alzheimer’s disease and the MAGNIFY study in geographic atrophy secondary to dry age-related macular degeneration. Enrollment for the SHIMMER study in dementia with Lewy bodies has been completed.

Cognition Therapeutics remains dedicated to discovering and developing innovative therapies for age-related degenerative disorders of the central nervous system and retina. Their lead candidate, CT1812, is under investigation in several clinical programs, and the company believes its approach, which targets the σ-2 receptor complex, offers a distinct functional benefit compared to other treatments.

The presentation at CTAD and subsequent discussions aim to provide further insights into CT1812’s potential and guide future clinical development efforts.