Cognition Therapeutics Advancing Zervimesine (CT1812) for Dementia with Lewy Bodies (DLB) Psychosis
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) plans to advance zervimesine (CT1812) toward a registrational program for Dementia with Lewy Bodies (DLB) psychosis after receiving final FDA Type C meeting minutes following a Jan 21, 2026 meeting.
The company cites positive Phase 2 SHIMMER neuropsychiatric and motor-safety signals and expects a randomized 100mg daily vs. placebo study with an open-label extension, and a midyear 2026 FDA Division of Psychiatry meeting.
Positive
- Pursuing registrational path for DLB psychosis after FDA Type C minutes
- Phase 2 SHIMMER showed favorable neuropsychiatric signals without motor impairment
- Planned randomized study: 100mg daily vs. placebo with open-label extension
- Regulatory engagement expected: FDA Division of Psychiatry meeting by midyear 2026
Negative
- No approved treatments currently exist for DLB psychosis
- Approval not guaranteed; further pivotal trials and FDA alignment required
- Clinical risk: efficacy must be confirmed in larger registrational studies
Key Figures
Market Reality Check
Peers on Argus
CGTX fell 6.03% while peers TRDA (-7.73%), TNYA (-7.75%), PRQR (-1.85%) and VYGR (-1.91%) also declined, with TLSA flat. The downside move aligns with broader biotech weakness rather than a clearly isolated reaction.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 05 | DLB EAP extension | Positive | -2.9% | Extended DLB expanded access program to gather more long-term safety data. |
| Jan 27 | FDA Type C recap | Positive | -4.3% | Reported productive FDA Type C meeting on endpoints for next DLB study. |
| Jan 06 | Phase 2 SHIMMER data | Positive | +0.7% | Published Phase 2 DLB results showing safety and favorable clinical effects. |
| Dec 03 | EAP full enrollment | Positive | +11.8% | Reached full enrollment in DLB expanded access with 100 mg daily dosing. |
| Dec 01 | AD Phase 3 plan | Positive | -7.5% | Outlined Phase 3 plan for Alzheimer’s with strong Phase 2 subgroup data cited. |
Recent CGTX news on zervimesine has generally been positive, but price reactions have often been negative, showing several divergences between upbeat clinical/regulatory updates and short-term stock performance.
Over the past few months, Cognition has steadily advanced zervimesine in dementia with Lewy bodies. Phase 2 SHIMMER data for DLB were published on Jan 6, 2026 with a modest 0.71% gain, while FDA Type C meeting updates on Jan 27, 2026 and the expanded access extension on Feb 5, 2026 saw declines of 4.35% and 2.94%. Earlier, full enrollment in the DLB expanded access program on Dec 3, 2025 produced an 11.8% rise. Today’s news fits the ongoing DLB-focused development narrative but continues a mixed pattern of market reactions.
Regulatory & Risk Context
An effective S-3 shelf filed on Dec 18, 2025 allows Cognition to offer up to $300,000,000 in various securities, including up to $75,000,000 of common stock via an at-the-market program with Jefferies, providing substantial capacity to raise capital for development and corporate purposes.
Market Pulse Summary
This announcement outlines Cognition’s plan to pursue a registrational path for zervimesine in dementia with Lewy bodies psychosis, supported by Phase 2 SHIMMER data and recent FDA Type C meeting feedback. The next study will evaluate neuropsychiatric symptoms at a 100 mg daily dose with a potential open-label extension. Investors may track upcoming FDA Division of Psychiatry discussions by midyear 2026 and the design of future trials as key milestones.
Key Terms
dementia with lewy bodies medical
benzodiazepines medical
open-label extension clinical
placebo clinical
AI-generated analysis. Not financial advice.
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
“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
About the Phase 2 SHIMMER Study
The SHIMMER study (NCT05225415) 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
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 (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 DLB 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: the FDA may disagree with our planned clinical study plan and determine that additional studies and/or data are required; 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 did Cognition announce on March 2, 2026 about CT1812 (CGTX)?
What is the planned clinical design for the DLB psychosis study for CGTX?
When will Cognition meet the FDA to discuss the DLB psychosis program for CGTX?
What evidence supports zervimesine for DLB psychosis for CGTX investors?
How common is psychosis in DLB patients mentioned in the CGTX announcement?
Does the March 2, 2026 announcement indicate zervimesine is approved for DLB psychosis?
