Cognition Therapeutics Completes Enrollment in Phase 2 Study of Zervimesine (CT1812) in Early Alzheimer's Disease
1. Cognition completes enrollment for 540 participants in Phase 2 START Study.
2. START Study evaluates zervimesine's safety in Alzheimer's patients.
3. Strong interest contributed to high enrollment, especially in the last six months.
4. Combination therapy potential for patients receiving approved monoclonal antibody therapies.
5. Zervimesine aims to alleviate burdens on patients and healthcare providers.
The successful completion of participant enrollment in the ongoing clinical trial suggests potential positive outcomes, which could stimulate investor interest similar to past positive clinical trials in biopharma. Companies with significant advancements often see rising stock prices; for example, Biogen's stock rose significantly following favorable trial results for Alzheimer's treatments.
How important is it?
The article contains crucial updates on the Phase 2 START Study and potential market position, which could influence CGTX's share price. As clinical trials often dictate a biopharmaceutical company's market valuation, investor interest can shift significantly based on the outcome.
Why Long Term?
The anticipated results from the trial will be available after 18 months, indicating a future impact period. Historical trends show that positive clinical trial results can enhance stock performance long-term, such as with companies like Acadia Pharmaceuticals following similar timelines.
PURCHASE, N.Y., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ:CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START' Study. A number of additional patients are in the final stages of screening and will be randomized if they meet all eligibility requirements. START will assess the safety and activity of zervimesine (CT1812) in participants with mild cognitive impairment (MCI) or early Alzheimer's disease. Topline results are expected after all participants have completed 18 months of treatment.
"Our clinical operations teams drove impressive enrollment numbers this year based on strong interest from patients and investigators," stated Lisa Ricciardi, Cognition's president and CEO. "During the first half of 2025, we made presentations of our Phase 2 results in mild-to-moderate Alzheimer's disease and dementia with Lewy bodies at international conferences and to the START investigators. The interest generated among investigators contributed to the strong enrollment figures, with approximately 50% of the entire study population enrolled during the last six months. We would like to thank our partners at ACTC and our investigators for their commitment, which led to this impressive accomplishment."
The START study was initiated shortly after Leqembi was granted accelerated approval in the US. Cognition and ACTC made the decision to allow people on stable background therapy with an approved monoclonal antibody therapy to participate. Approximately 15% of participants randomized into START were also receiving infusions of either Leqembi (lecanemab) or Kisunla (donanemab).
Dr. Ryan O'Dell, MD, PhD, assistant professor of psychiatry at the Yale Alzheimer's Disease Research Unit and an investigator in the START study, added, "It's an exciting time to be involved in Alzheimer's disease research. With two approved anti-amyloid antibodies, many of our patients finally have new treatment options. But these disease-modifying therapies are only appropriate for some patients, leaving many with MCI and mild dementia due to Alzheimer's disease, and the entire spectrum of people with more severe disease, without access to these novel treatments. The START study was a unique opportunity to investigate an experimental oral drug with a mechanism that is unlike that of the currently approved immunotherapeutics, with the potential to treat a broader segment of the Alzheimer's patient community. And the prospect of combination therapy is particularly exciting for those patients receiving background Leqembi or Kisunla infusions as part of their clinical care."
"We expect zervimesine's oral dosing and safety profile, with no increased risk of ARIA or need for serial imaging, to reduce the burden on patients and healthcare providers," concluded Anthony O. Caggiano, Cognition's chief medical officer. "We believe zervimesine has the potential to be an important part of the Alzheimer's disease treatment arsenal for patients with early, mild and moderate Alzheimer's disease."
About the START Study The START Study (NCT05531656) is designed to measure the efficacy and tolerability of once-daily oral zervimesine in individuals with mild cognitive impairment (MCI) or early Alzheimer's disease who have elevated Aβ as measured by PET or CSF. Participants are randomized to receive zervimesine or placebo for 18 months. The study will measure cognition and executive function using validated tools including the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales. Biomarkers and safety findings will also be assessed.
The START Study is supported by an $81 million grant from the National Institute of Aging (NIA) at the National Institutes of Health (R01AG065248). The study is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC), an NIA-funded (grant number U24AG057437) clinical trial network of 35 leading academic sites with expertise in clinical trials in Alzheimer's disease.
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. If zervimesine can interrupt the toxic effects of these proteins, it may be able to 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.
The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.
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 (NCT05531656) 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 https://cogrx.com.
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 call, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements related to our clinical studies of zervimesine (CT1812), including our Phase 2 START study, and any analysis of the results or timing of the results therefrom; any expected or implied benefits or results of zervimesine, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, 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 global political changes and global economic conditions, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; 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 www.sec.gov. 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.
Contact Information: Cognition Therapeutics, Inc. info@cogrx.com
