Cognition Therapeutics' Phase 2 SHINE Trial Shows Cognitive Improvement with Daily CT1812 in Mild-to-Moderate Alzheimer's Patients

Cognition Therapeutics, Inc. (Cognition), a clinical-stage company focused on developing drugs for neurodegenerative disorders, has announced promising results from their proof-of-concept Phase 2 'SHINE' study. This study evaluated the efficacy of CT1812, a novel treatment for mild-to-moderate Alzheimer's disease. Findings revealed significant cognitive improvement in participants receiving the drug, compared to those on placebo.

The SHINE study enrolled 153 adults with mild-to-moderate Alzheimer's disease, who were randomly assigned to receive either a placebo or one of two dosages of CT1812 (100mg or 300mg) daily for six months. Cognitive functions were assessed using several measures, including ADAS-Cog 11, ADAS-Cog 13, and MMSE. Notably, the study observed meaningful changes in functional measures as well.

Patients treated with CT1812 showed a consistent trend of cognitive improvement across all measures. For example, on the ADAS-Cog 11 scale, those on placebo experienced a decline of 2.70 points, whereas participants on CT1812 showed a lesser decline of 1.66 points, translating to a 39% slowing of cognitive decline. Similar positive trends were noted in the MMSE scores.

In terms of safety, CT1812 demonstrated a favorable profile with most treatment-related adverse effects being mild or moderate. The majority of side effects included common ailments such as urinary tract infections, falls, skin lacerations, headaches, and gastrointestinal issues. CT1812-treated participants experienced fewer serious adverse events (6% compared to 10% in the placebo group).

Additionally, the study uncovered significant changes in neurofilament light chain (NfL) levels, a marker of neurodegeneration, particularly at the 300mg dose. This finding supports the potential role of CT1812 as a synaptoprotective agent. Other cerebrospinal fluid (CSF) biomarkers did not show significant changes.

Lisa Ricciardi, President, and CEO of Cognition Therapeutics, highlighted the importance of these findings for future clinical development. She emphasized that the observed improvements in cognitive function and safety profile are comparable to currently approved treatments, with the added benefit of easier administration. Ricciardi also expressed optimism about CT1812's potential as both a monotherapy and in combination with other approved drugs for treating Alzheimer's and related dementias.

Anthony Caggiano, Cognition's Chief Medical Officer, reiterated the significance of the cognitive benefits observed in the study. He mentioned that these results would guide the design of future clinical trials, specifically targeting the 100mg dose for further investigation in a mild-to-moderate patient population.

The SHINE study achieved its primary objective of demonstrating a favorable safety and tolerability profile for CT1812. The percentage of participants experiencing adverse events was similar between the treatment and placebo groups. Moreover, liver function tests (LFTs) showed no serious liver injury in the 100mg dose group, though some LFT increases were observed at the 300mg dose, which resolved after discontinuation of the drug.

Ricciardi also pointed to ongoing studies, including the SHIMMER trial for mild-to-moderate Lewy body dementia and the START trial for early-stage Alzheimer's disease. This comprehensive research effort aims to provide more treatment options for neurodegenerative diseases.

Cognition Therapeutics remains committed to advancing research in this field, supported by substantial grant funding from several institutions, including the NIH and NIA. The company continues to explore the potential of CT1812 and other therapies in their pipeline to address neurodegenerative disorders and improve patient outcomes.