New Data: Zervimesine for the Treatment of Dementia With Lewy Bodies and Alzheimer Disease

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CONFERENCE REPORTER

Cognition Therapeutics presented new data on zervimesine (CT1812) in dementia with Lewy bodies (DLB) and Alzheimer disease at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-30).¹

This included results from the phase 2 COG1201 SHIMMER study (NCT05225415) of zervimesine (CT1812) in DLB, results from the phase 2 COG0201 SHINE study (NCT03507790) of zervimesine in Alzheimer disease, and 2 additional posters supporting zervimesine’s efficacy.

SHIMMER Study

James E. Galvin, MD, MPH, the SHIMMER study director, presented findings during a Featured Research Session on July 29, 2025. Investigators of the SHIMMER study randomly assigned 130 adults with mild-to-moderate DLB who took a daily oral dose of zervimesine or placebo for 6 months. The study met its primary endpoint of safety and tolerability. Results showed that zervimesine treatment had a positive impact across neuropsychiatric, cognitive, motor, and functional scales. After 6 months of treatment, patients with DLB who were treated with zervimesine scored an average of 86% better than patients receiving placebo on the neuropsychiatric inventory (NPI-12), a tool that measures 12 separate behavioral symptoms that are hallmarks of DLB.²

“Among the NPI-12 components, hallucinations, delusions, and anxiety are often considered most troubling to patients and their care partners,” said Galvin, who is also the director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine. “These behavioral symptoms are also some of the most challenging to treat, since DLB patients have severe and sometimes dangerous reactions to many commonly used neuropsychiatric drugs. This made zervimesine’s impact even more notable.”

SHINE Study

The SHINE study is a phase 2 signal-finding trial that enrolled 153 adults with mild-to-moderate Alzheimer disease who were evenly randomized to receive either placebo or 1 of 2 doses of CT1812 (100 mg or 300 mg), which was taken orally daily for 6 months. The SHINE study met its primary endpoint of safety and tolerability. An analysis was conducted on a subgroup of participants whose Alzheimer disease brain pathology was less pronounced, as determined by lower levels of a protein called p-tau217 in their blood. Approximately half of this subgroup was identified as having mild Alzheimer disease and half with moderate Alzheimer disease by the mini mental state exam (MMSE). SHINE participants with lower p-tau217 had a more robust response to zervimesine compared with those with higher p-tau217 levels, regardless of their MMSE scores. Zervimesine was shown to arrest further cognitive deterioration in individuals with mild or moderate Alzheimer disease by 129% and 91%, respectively.

“This was an important finding as we now know we can identify patients who are more likely to benefit from zervimesine treatment through a simple blood test for p-tau217,” said Anthony Caggiano, MD, PhD, the CMO and head of R&D at Cognition.

Poster Presentations

Additionally, 2 research posters presentations explored the mechanism that underlies the impact of zervimesine in Alzheimer disease. These posters summarize analyses of the cerebrospinal fluid (CSF) and plasma biomarkers from SHINE participants with lower levels of p-tau217. In these participants, significant reductions were observed in the level of plasma glial fibrillary acidic protein. In addition, there were trends towards the normalization of neurofilament light (NfL) and amyloid beta species (Aβ40 and 42).

“The biomarker evidence we are presenting at AAIC shows that zervimesine treatment had an effect on proteins involved in neuroinflammation, synapse health, and neurodegeneration,” said Mary Hamby, PhD, the VP of research at Cognition. “This is consistent with previously reported results showing significant decreases in NfL and normalizing trends in amyloid beta species in the CSF of people treated with zervimesine. This is encouraging evidence that zervimesine is impacting the underlying Alzheimer disease biology.”

Stay tuned for further updates on Alzheimer disease research and late-breaking conference data.

References

1. Cognition Therapeutics presents data at AAIC highlighting broad neurological impact of zervimesine (CT1812) in dementia with Lewy bodies and Alzheimer’s disease. News release. July 29, 2025. Accessed July 29, 2025. https://ir.cogrx.com/press_releases/cognition-therapeutics-presents-data-at-aaic-highlighting-broad-neurological-impact-of-zervimesine-ct1812-in-dementia-with-lewy-bodies-and-alzheimers-disease/

2. Cognition’s positive phase 2 ‘SHIMMER’ study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) will be presented in a podium presentation at ILBDC. News release. January 30, 2025. Accessed July 29, 2025. https://ir.cogrx.com/press_releases/cognitions-positive-phase-2-shimmer-study-of-zervimesine-ct1812-in-dementia-with-lewy-bodies-dlb-will-be-presented-in-a-podium-presentation-at-ilbdc/

3. Cognition Therapeutics announces results of pre-specified analysis of SHINE study data presented at CTAD. News release. October 29, 2024. Accessed July 29, 2025. https://ir.cogrx.com/press_releases/cognition-therapeutics-announces-results-of-pre-specified-analysis-of-shine-study-data-presented-at-ctad/