Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) presented a Phase 3 registrational plan for zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at CTAD on Dec 1, 2025. The company discussed design with the FDA during a July 2025 end-of-Phase 2 meeting and plans an EMA scientific advice meeting in February 2026 to align global strategy.
Key design elements: two randomized 1:1 six-month Phase 3 studies of 100 mg oral zervimesine daily, enrichment for patients with lower plasma p-tau217 at screening, efficacy measured by the iADRS, and eligibility for an open-label extension. Phase 2 SHINE data cited a 95% slowing of cognitive decline by ADAS-Cog11 in the lower p-tau subgroup versus placebo.
Positive
- Phase 3 plan uses FDA-agreed design elements
- Phase 2 subgroup showed 95% slowing of ADAS-Cog11 decline
- Two randomized 6-month studies with 100 mg oral dosing
- iADRS selected as a validated efficacy endpoint
Negative
- Enrollment restricted to lower p-tau217 may shrink eligible population
- Phase 3 relies on a Phase 2 subgroup result rather than overall cohort
Insights
Clear Phase 3 plan announced with FDA agreement on enrichment and endpoints; EMA alignment planned for global registration.
Cognition Therapeutics proposes two six-month, randomized 1:1 Phase 3 studies of 100 mg oral zervimesine versus placebo in adults with mild-to-moderate Alzheimer’s disease enriched for lower plasma p-tau217 at screening. The FDA agreed that enrichment by p-tau217 and efficacy assessment with the iADRS composite could support a registrational program, and participants may enter an open-label extension.
The program’s strength rests on the reported Phase 2 subgroup result showing a 95% slowing of cognitive decline on ADAS-Cog11 in lower p-tau217 patients; this underpins the biomarker-enrichment strategy but also concentrates risk on assay performance, screening feasibility, and reproducibility of that effect in broader Phase 3 cohorts. The company plans an EMA scientific advice meeting in
Watch for three concrete near-term items: publication/poster availability at CTAD (
- Seeking Alignment with European Medicines Agency (EMA) at February 2026 Meeting -
- Actively Evaluating Strategy Across DLB and Alzheimer’s Disease -
PURCHASE, N.Y., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented plans for a registrational program for zervimesine in mild-to-moderate Alzheimer's disease during the annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. Cognition discussed the program design with the U.S. Food and Drug Administration (FDA) during an end-of-Phase 2 meeting. The CTAD poster will be available on the Publications page of the company website in accordance with the conference embargo policy.
The Phase 3 program is expected to enroll adults with mild-to-moderate Alzheimer's disease who have lower levels of plasma p-tau217 at screening. Based on Phase 2 clinical study results, the Company believes that screening for p-tau217 levels will enrich the study population with patients most likely to benefit from zervimesine treatment. The U.S. Food and Drug Administration agreed with this approach during the July 2025 end-of-Phase 2 meeting.
“Results from the Phase 2 ‘SHINE’ study showed that participants treated with zervimesine who had lower plasma p-tau217 levels experienced a
FDA meeting minutes stated that two six-month Phase 3 studies with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily may be sufficient. Efficacy may be measured using the iADRS, a composite of the ADAS-Cog 13 and ADCS-ADL, validated scales measuring cognition and function. Participants who complete either study will be eligible to enroll in an open-label extension.
Lisa Ricciardi, president and CEO of Cognition, concluded, “Cognition Therapeutics is planning to conduct a scientific advice meeting with the European Medicines Agency (EMA) to align global Alzheimer’s disease registrational plans with those discussed with FDA in July. We are actively evaluating our resources across dementia with Lewy bodies (DLB) and Alzheimer’s disease.”
CTAD Poster Details:
Conference: December 1-4, 2025 in San Diego, CA
Session: Clinical Trials: Methodology, December 1-2, 2025
Poster Title: Alzheimer’s Disease Pivotal Trial Design for Zervimesine Following an End-of-Phase 2 Meeting with FDA
Authors: Jennifer F. Iaci, MS, Michael Grundman, MD, MPH, Nigel A.S. Hernandez, PhD, MSc, RAC, and Anthony O. Caggiano, MD, PhD
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 receptors on the surface of 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.
The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.
About the SHINE Study
The COG0201 ‘SHINE’ Study was a double-blind, placebo-controlled Phase 2 study that enrolled 153 adults with mild-to-moderate Alzheimer’s disease. The study met its primary endpoints of safety and tolerability. Changes in cognition (ADAS-Cog 11, cognitive composite and MMSE) and function (ADCS-ADL and ADCS-CGIC) were also measured. Participants were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months.
The SHINE Study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately
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 with
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 zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory plans, including our designs and plans for our Phase 3 program, 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; 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 | Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
This press release was published by a CLEAR® Verified individual.
FAQ
What Phase 3 design did Cognition Therapeutics (CGTX) present for zervimesine on Dec 1, 2025?
What biomarker enrollment criterion will CGTX use in the zervimesine Phase 3 trials?
What Phase 2 result supports Cognition's Phase 3 plan for CGTX zervimesine?
Has the FDA agreed with Cognition's proposed Phase 3 approach for CGTX?
Will CGTX seek alignment with European regulators for zervimesine?
