Cognition Therapeutics Extends Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies

PURCHASE, N.Y., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, has extended the duration of the expanded access program (EAP) for dementia with Lewy bodies (DLB). The program, which was originally expected to provide each participant with twelve months of treatment, will now allow several more months of treatment.

“The EAP has been running since June 2025 and is expected to provide us with additional long-term safety data,” stated , Cognition's chief medical officer. “We’ve received favorable feedback during the program from participants and their care partners about their experience in this program. We implemented a strategy that reduces the amount of travel for patients to clinical sites by empowering their local physicians to conduct routine health monitoring and allowing local laboratory testing. Doctors and patients appreciate these operational aspects of the program.”

Thirty-two individuals were enrolled at eight sites in this open-label EAP, each of whom are being treated with 100 mg of oral zervimesine daily. Banner Sun Health Research Institute in Arizona was the first site to be activated and enrolled the first participants. David Shprecher, DO Msci is the primary investigator at Banner and provided feedback to the Cognition team during the design of the EAP.

“The Cognition team sought input from myself and other investigators in the design of this EAP to maximize the number of participants who could enroll with the limited resources available,” explained Dr. Shprecher. “With only eight clinical sites around the country able to participate, patients would need to travel long distances for clinic visits. Working together, we devised a system that would enable patients to see their local doctors for routine visits while traveling to clinic sites for more rigorous monitoring.”

The EAP is part of the company’s larger clinical development program in DLB, which included the Phase 2 SHIMMER study and planned clinical programs. Cognition Therapeutics conducted a Type C meeting with the U.S. Food and Drug Administration (FDA) on January 21, 2026 to review findings from the SHIMMER study. The meeting focused on the use of clinically meaningful endpoints in future studies of DLB. Meeting minutes are expected in February.

About the EAP

The COG1202 expanded access program (EAP) is an open-label program for eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who meet the enrollment criteria. Dr. James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine is acting as lead investigator for the EAP. As an investigational medicine, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. More information is available on under study identifier NCT06961760.

About 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. 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 

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of and expanded access to zervimesine, any analyses of the results therefrom and our expectations regarding data and development programs for zervimesine, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at . These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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