Cognition Therapeutics Advancing Zervimesine (CT1812) for Dementia with Lewy Bodies (DLB) Psychosis

We believe regulatory strategy expedites development of potential first treatment to address DLB psychosis

PURCHASE, N.Y., March 02, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced plans to advance development of zervimesine for the treatment of dementia with Lewy bodies (DLB) psychosis, which impacts as many as 75% of patients. This follows receipt of final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the Type C meeting that was conducted on January 21, 2026.

“Based on the Agency’s meeting minutes and the strength of our Phase 2 ‘SHIMMER’ data in the psychiatric and behavioral domain, we believe the best strategy is to pursue a registrational path for the treatment of DLB psychosis,” explained Anthony O. Caggiano, MD, PhD, Cognition’s CMO. “Symptoms of DLB psychosis are reported to be extremely debilitating and often lead to institutionalization. Since DLB patients are unable to tolerate many antipsychotic medications, there is a need for treatments developed for this specific population. We believe that zervimesine has the potential to make a meaningful difference in the lives of DLB patients and their families.”

As planned, the next study for DLB will focus on the measurement of neuropsychiatric symptoms such as hallucinations and delusions, and behavioral symptoms such as anxiety, aggression, and agitation. We expect symptoms will be measured using established validated endpoints. Participants will be randomized to either 100mg of oral zervimesine or placebo daily for the study period, after which participants would be eligible to enroll in an open-label extension study. Cognition expects to meet with the FDA Division of Psychiatry to discuss a DLB psychosis program by midyear 2026.

“There are no approved medications for DLB psychosis, which effects a majority of patients with the disease,” concluded Lisa Ricciardi, Cognition’s president and CEO. “Traditional antipsychotics and benzodiazepines can worsen motor function in DLB patients. We showed in Phase 2 that zervimesine’s impact on neuropsychiatric symptoms did not impair participants’ motor skills. In fact, zervimesine had a directionally favorable impact on cognitive fluctuations, memory, movement, and activities of daily living. Subject to alignment with the FDA, we believe this regulatory program will allow us to expedite zervimesine’s path to market, where it can meet a critical need for DLB patients.”

DLB Psychosis
Patients with dementia commonly experience behavioral and psychological symptoms such as hallucinations, aggression, agitation, and depression. As many as 75% of patients with DLB will experience psychosis, which presents a considerable burden to patients and caregivers. In addition to impeding daily activities, neuropsychiatric symptoms lead to higher healthcare costs and earlier institutionalization. While antipsychotics are available for other conditions, none are approved for use in DLB patients. In fact, many traditional antipsychotics, such as haloperidol, are contraindicated in patients with DLB, who may exhibit severe parkinsonism, sedation, and immobility in response to these medications.

About the Phase 2 SHIMMER Study
The SHIMMER study is 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. Findings show that zervimesine had a positive impact across symptom domains. The candidate’s impact on neuropsychiatric symptoms was particularly robust, resulting in an 86% slowing of decline on 12-item neuropsychiatric inventory (NPI-12) vs placebo. 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 Zervimesine (CT1812)
Zervimesine (CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain – Aβ and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person’s ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. Zervimesine has been shown to interrupt the toxic effects of Aβ and ɑ-synuclein, which may slow progression of disease and improve the lives of those suffering from Alzheimer’s and DLB. Zervimesine has been generally well tolerated in clinical studies to date.

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 studies 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 with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. 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.

This press release was published by a CLEAR® Verified individual.