Study on Zervimesine for Alzheimer Disease Reaches Enrollment Target

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Cognition Therapeutics announced this week that their phase 2 START study for zervimesine (CT1812) has reached 75% enrollment.¹ The study will measure efficacy of once-daily, oral zervimesine in treating individuals with elevated Ab plaques from mild cognitive impairment (MCI) or early Alzheimer disease.

The study currently has approximately 540 participants, which marked the goal of 75% enrollment completion. During the trial, patients will be randomly grouped to be treated with zervimesine or placebo for 18 months. Patient eligibility requires elevated A-beta, measured by positron emission tomography scans or cerebrospinal fluid analysis. Participants will be assessed for cognition and executive function using tools including the Clinical Dementia Rating Scale Sum of Boxes and ADAS-Cog rating scales. The study will also collect biomarker and safety information.

A previous study on zervimesine, the SHINE phase 2 study, gathered data from 153 adults with mild to moderate Alzheimer disease, and ultimately met safety and tolerability goals.² The study compared placebo, 100 mg treatment, and 300 mg treatment groups over 6 months. Results from the SHINE study indicated that zervimesine can slow cognitive deterioration in patients with lower levels of p-tau217.³ This earlier study and the current START study are conducted in a collaboration with the Alzheimer’s Clinical Trials Consortium and received funding from the National Institute of Aging.

Zervimesine is a once-daily, orally administered pill intended to treat Alzheimer disease. It can also treat other central nervous system diseases like Lewy body dementia. Because Alzheimer disease and Lewy body dementia are both related to excess buildup of A-beta and alpha-synuclein, zervimesine may treat these diseases by blocking the effects of these proteins which damage neurons and can destroy them over time. By changing the ability of these proteins to affect neurons, progression of Alzheimer disease could be slowed. The drug works to prevent A-beta oligomers from binding to synapses, potentially having a neuroprotective effect.⁴ By working earlier in the amyloid cascade, the medication differs from many prior efforts to develop drugs that focus on removing A-beta plaques from the brain. In clinical studies conducted thus far, zervimesine has been well tolerated by patients.

President and CEO of Cognition Therapeutics, Lisa Ricciardi, said in a press release, “We believe the strong enrollment pace in the START Study is due to interest on the part of patients and investigators in the potential of a convenient, once-daily oral medication,” adding that “the START Study is our largest phase 2 trial to date and our second in Alzheimer’s disease…We look forward to building an understanding of zervimesine’s potential across the Alzheimer’s spectrum.”

References

1. Cognition Therapeutics study of zervimesine (CT1812) in early Alzheimer’s disease reaches enrollment target. Press release. September 3, 2025. Accessed September 4, 2025. https://www.biospace.com/press-releases/cognition-therapeutics-study-of-zervimesine-ct1812-in-early-alzheimers-disease-reaches-75-enrollment-target

2. Cognition Therapeutics announces results of pre-specified analysis of SHINE study data presented at CTAD. Cognition Therapeutics. October 29, 2024. Accessed September 4, 2025. https://ir.cogrx.com/press_releases/cognition-therapeutics-announces-results-of-pre-specified-analysis-of-shine-study-data-presented-at-ctad/

3. Kuntz L. New data: zervimesine for the treatment of dementia with Lewy bodies and Alzheimer disease. Psychiatric Times. July 29, 2025. Accessed September 4, 2025. https://www.psychiatrictimes.com/view/new-data-zervimesine-for-the-treatment-of-dementia-with-lewy-bodies-and-alzheimer-disease

4. Alzheimer’s disease. Cognition Therapeutics. https://cogrx.com/pipeline/alzheimers-disease-moa/