Cognition Therapeutics reports once-daily drug’s potential to slow Alzheimer’s progression, showing promise with favorable safety profile.
Cognition Therapeutics, Inc. recently disclosed findings from their Phase 2 SHINE trial, investigating the efficacy of CT1812, an experimental oral treatment for Alzheimer’s disease. The study, which involved 153 adults with mild-to-moderate Alzheimer’s, assessed the cognitive and functional impacts of daily CT1812 doses over six months, and has reported approximately 40% less cognitive decline in patients administered CT1812 compared with those on a placebo.
The SHINE trial, a double-blind, placebo-controlled study, explored two dosages of CT1812 (100mg and 300mg), with the primary objective being the safety and tolerability of the treatment. The drug showed a consistent trend towards cognitive improvement across multiple measures, including an Alzheimer’s Disease Assessment Scale that involved 11 different tasks (ADAS-Cog 11) and a Mini-Mental State Examination based on 11 questions (MMSE). Specifically, by Day 182, participants on placebo experienced a 2.70-point decline on the ADAS-Cog 11 scale, while those on CT1812 showed a lesser decline of 1.66 points – indicating a 39% reduction in cognitive decline in favor of the treatment.
Dr Anthony Caggiano, Chief Medical Officer of Cognition Therapeutics, remarked: “A key objective of this trial was to provide evidence of cognitive benefit potential with CT1812 treatment, which we accomplished.” He further noted the consistent cognitive effect and signals of functional benefit observed throughout the study.
While CT1812 did not reach statistical significance on some secondary endpoints, exploratory measures indicated potential functional benefits, particularly in the 100mg dose group. Moreover, significant changes were noted in neurofilament light chain (NfL) levels – a biomarker associated with neurodegeneration – especially in patients receiving the 300mg dose. This suggests that CT1812 may act as a synaptoprotective agent, potentially protecting against further neurodegenerative damage.
The global burden of Alzheimer’s disease continues to rise, with millions of individuals and their families affected by this debilitating condition. There is an urgent need for therapeutics that can slow or halt the progression of the disease, especially those that are easily administered and have a favorable safety profile; CT1812’s once-daily oral administration offers a promising alternative to currently available treatments, which often require more invasive administration routes and may come with significant side effects.
Cognition Therapeutics’ CEO, Lisa Ricciardi, emphasized the potential of CT1812, stating: “These results provide evidence that amyloid oligomer antagonism – a new and distinct mechanism for therapeutic intervention – may have a role as a monotherapy or in combination with approved drugs for the treatment of AD and related dementias.” She also highlighted the drug’s ease of administration and lower patient burden compared with other treatments.
The trial’s safety profile was encouraging, with most adverse events being mild or moderate. Notably, serious adverse events (SAEs) were less frequent in the CT1812 groups (6%) compared with the placebo group (10%). Furthermore, transient liver function test (LFT) increases were observed in some patients on the 300mg dose, but these resolved upon discontinuation, without causing serious liver injury.
As the Alzheimer’s research community continues to search for effective treatments, the SHINE study’s findings offer a glimmer of hope. The consistent cognitive improvements and manageable safety profile of CT1812 suggest that it could become a valuable addition to the therapeutic landscape. Cognition Therapeutics plans to build on these results with further trials, including the ongoing SHIMMER study for Lewy body dementia and the START study targeting early-stage Alzheimer’s disease.
