Cognition Therapeutics Publishes Phase 2 Clinical Results Showing Zervimesine’s Potential to Slow the Progression of Dementia with Lewy Bodies

PURCHASE, N.Y., Jan. 06, 2026 (GLOBE NEWSWIRE) -- (NASDAQ: CGTX), today announced that a manuscript entitled, “Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)” (doi: ) has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer’s Association. Results from this study were first presented in January 2025 at the in Amsterdam.

“The Phase 2 SHIMMER study, our first in DLB, met its primary goal of confirming zervimesine’s safety and tolerability,” explained , Cognition’s chief medical officer. "Importantly, zervimesine was also shown to have a favorable impact on behavioral, cognitive, functional, and movement domains, many of which are core clinical features of DLB. There are currently no approved disease-modifying treatments for DLB, highlighting the unmet need for novel therapies.”

The Phase 2 SHIMMER study randomized 130 adults with mild-to-moderate who took a daily oral dose of zervimesine or placebo for six months. The study met its primary endpoint of safety and tolerability. In addition, after six months of treatment, zervimesine-treated participants’ neuropsychiatric symptoms improved relative to placebo as measured by the neuropsychiatric inventory (NPI). The NPI assesses the frequency and severity of 12 separate behavioral symptoms, including hallucinations, delusions, anxiety and agitation. These symptoms are hallmarks of DLB and can be especially debilitating for patients.

Zervimesine treatment also resulted in an improvement in fluctuations, which are described as unpredictable lapses in attention or consciousness that can last for minutes, hours or days. After six months on zervimesine, participants experienced fewer and/or shorter cognitive fluctuations, compared to placebo-treated participants. Activities of daily living such as dressing, bathing, and writing, were also improved relative to placebo after six months of zervimesine treatment. Most treatment-related adverse events were mild or moderate, consistent with previous clinical experience.

“DLB has a number of complex symptoms, which can make it difficult to care for patients at home as their disease worsens.” added , Cognition’s president and CEO. “Zervimesine showed meaningful impact across symptom domains including behavior, cognition, fluctuations, and motor function. This represents a clinically meaningful impact for DLB patients and their caregivers.”

The U.S. Food and Drug Administration (FDA) will meet Cognition during a Type C meeting scheduled for the second half of January 2026. During the meeting, the next clinical studies for zervimesine in DLB will be discussed, with a focus on clinically meaningful endpoints. Meeting minutes are expected to follow the Type C meeting.

Publication Citation:

Galvin JE, Tolea MI, Scharre DW, et al. Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB). . 2025; 21:e71004.

About the SHIMMER Study

The SHIMMER study () was an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, who were randomized to either daily oral doses of zervimesine (100 mg or 300 mg) or placebo for six months. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.

The SHIMMER study was supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million (R01AG071643) and was conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA).

About Cognition Therapeutics, Inc.

Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We recently completed Phase 2 of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The Phase 2 START Study () in early Alzheimer’s disease is ongoing. We believe zervimesine can regulate pathways that are impaired in these diseases through its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at .

Forward Looking Statements

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Contact Information:

Cognition Therapeutics, Inc. 

Mike Moyer (investors)

LifeSci Advisors