Cognition Therapeutics reported that the manuscript detailing its Phase 2 SHIMMER study has been published in Alzheimer’s & Dementia. The study, a double‑blind, placebo‑controlled trial of 130 adults with mild‑to‑moderate Dementia with Lewy Bodies (DLB), evaluated daily oral zervimesine (CT1812) versus placebo over six months and met its primary safety and tolerability endpoint.
The trial demonstrated clinically meaningful improvements across multiple symptom domains. Patients receiving zervimesine experienced an 82 % reduction in neuropsychiatric inventory scores, an 86 % improvement on the Neuropsychiatric Inventory‑Questionnaire (NPI), and a 91 % decrease in cognitive fluctuation severity compared with placebo. Motor function, measured by the Unified Parkinson’s Disease Rating Scale Part III, improved by 12 % relative to baseline, while activities of daily living scores improved by 10 %. These results represent the first peer‑reviewed evidence of efficacy for a sigma‑2 receptor modulator in DLB.
Safety data were favorable. The incidence of adverse events was 38 % in the zervimesine group versus 35 % in placebo, with most events classified as mild or moderate. No serious adverse events or deaths were reported, and the drug was well tolerated over the six‑month period.
Chief Medical Officer Anthony Caggiano highlighted the breadth of the benefit: “Zervimesine showed meaningful impact across behavior, cognition, fluctuations, and motor function, addressing core clinical features of DLB.” President and CEO Lisa Ricciardi added, “These results confirm the therapeutic potential of CT1812 and strengthen our pipeline for both DLB and Alzheimer’s disease.”
The publication positions Cognition to advance regulatory discussions with the FDA, including a Type C meeting scheduled for the second half of January 2026. The company also signals readiness to pursue partnership opportunities that could accelerate development and commercialization of zervimesine.
Analysts have responded positively to the data, noting that the robust efficacy and safety profile could accelerate regulatory approval and broaden the company’s market reach. The study’s outcomes reinforce Cognition’s strategy to develop sigma‑2 receptor modulators as disease‑modifying therapies for neurodegenerative disorders.
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