Cognition Therapeutics Publishes Phase 2 Clinical Results Showing Zervimesine’s Potential to Slow the Progression of Dementia with Lewy Bodies
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) published Phase 2 SHIMMER results showing that oral zervimesine (CT1812) was safe and tolerated and produced favorable effects versus placebo across behavioral, cognitive, functional and movement measures in mild-to-moderate dementia with Lewy bodies (DLB).
The randomized study enrolled 130 participants who received daily dosing for six months. Zervimesine improved neuropsychiatric inventory (NPI) scores, reduced cognitive fluctuations, and improved activities of daily living versus placebo. Most treatment-related adverse events were reported as mild or moderate. A Type C meeting with the FDA is scheduled for the second half of January 2026 to discuss next DLB studies.
Positive
- Safety endpoint met in Phase 2 SHIMMER study of 130 participants
- NPI behavioral symptoms improved after six months versus placebo
- Fewer or shorter cognitive fluctuations after six months
- Improved activities of daily living versus placebo at six months
- Observed improvements across behavior, cognition, and motor domains
Negative
- Most treatment-related adverse events occurred, albeit mild or moderate
- Phase 2 limited to 130 participants over six months, requiring larger trials
News Market Reaction 13 Alerts
On the day this news was published, CGTX gained 0.71%, reflecting a mild positive market reaction. Argus tracked a peak move of +7.5% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $977K to the company's valuation, bringing the market cap to $139M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus 1 Up
Peers showed mixed moves, with names like TRDA up 2.94% and TNYA down 4.16%, pointing to stock-specific rather than sector-wide drivers for CGTX.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 03 | DLB access update | Positive | +11.8% | Expanded access program for DLB reached full enrollment and FDA Type C planned. |
| Dec 01 | Alzheimer’s Phase 3 plan | Positive | -7.5% | Presented Phase 3 registrational plan for Alzheimer’s disease at CTAD conference. |
| Nov 20 | Conference participation | Neutral | -4.3% | Announced CEO participation in a fireside discussion at a major healthcare conference. |
| Nov 13 | START enrollment complete | Positive | -10.5% | Completed target enrollment of 540 participants in Phase 2 START Alzheimer’s study. |
| Nov 06 | Q3 earnings & funding | Positive | -1.8% | Reported Q3 results, $30M offering, FDA alignment and runway into Q2 2027. |
Clinical and program updates have produced mixed reactions, with several positive-sounding catalysts followed by negative price moves.
Over the last few months, Cognition reported financing, regulatory alignment and steady clinical progress for zervimesine across Alzheimer’s disease, dementia with Lewy bodies and geographic atrophy. Notable events included a $30.0M registered direct offering, full enrollment of the START Phase 2 Alzheimer’s study with 540 participants, and completion of enrollment in a DLB expanded access program. Despite this, several ostensibly positive clinical and planning updates drew negative price reactions, underscoring choppy sentiment into today’s Phase 2 DLB publication.
Regulatory & Risk Context
An effective S-3 shelf filed on 2025-12-18 allows Cognition Therapeutics to offer up to $300,000,000 of securities, including a separate $75,000,000 ATM with Jefferies, providing substantial financing flexibility and potential future equity dilution.
Market Pulse Summary
This announcement details peer‑reviewed Phase 2 SHIMMER results in dementia with Lewy bodies, confirming zervimesine’s safety and showing improvements across behavioral, cognitive, functional and movement domains. It also notes an upcoming FDA Type C meeting to discuss next DLB studies and endpoints. In parallel, Cognition has significant financing flexibility via an effective shelf for up to $300,000,000, so investors may watch how future trial designs and capital usage evolve.
Key Terms
phase 2 medical
dementia with lewy bodies medical
neuropsychiatric inventory medical
adverse events medical
AI-generated analysis. Not financial advice.
- Zervimesine exhibited meaningful improvement in behavioral, functional, cognitive, and movement measures compared to placebo -
PURCHASE, N.Y., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), today announced that a manuscript entitled, “Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)” (doi: 10.1002/alz.71004) has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer’s Association. Results from this study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam.
“The Phase 2 SHIMMER study, our first in DLB, met its primary goal of confirming zervimesine’s safety and tolerability,” explained Anthony O. Caggiano, Cognition’s chief medical officer. "Importantly, zervimesine was also shown to have a favorable impact on behavioral, cognitive, functional, and movement domains, many of which are core clinical features of DLB. There are currently no approved disease-modifying treatments for DLB, highlighting the unmet need for novel therapies.”
The Phase 2 SHIMMER study randomized 130 adults with mild-to-moderate DLB who took a daily oral dose of zervimesine or placebo for six months. The study met its primary endpoint of safety and tolerability. In addition, after six months of treatment, zervimesine-treated participants’ neuropsychiatric symptoms improved relative to placebo as measured by the neuropsychiatric inventory (NPI). The NPI assesses the frequency and severity of 12 separate behavioral symptoms, including hallucinations, delusions, anxiety and agitation. These symptoms are hallmarks of DLB and can be especially debilitating for patients.
Zervimesine treatment also resulted in an improvement in fluctuations, which are described as unpredictable lapses in attention or consciousness that can last for minutes, hours or days. After six months on zervimesine, participants experienced fewer and/or shorter cognitive fluctuations, compared to placebo-treated participants. Activities of daily living such as dressing, bathing, and writing, were also improved relative to placebo after six months of zervimesine treatment. Most treatment-related adverse events were mild or moderate, consistent with previous clinical experience.
“DLB has a number of complex symptoms, which can make it difficult to care for patients at home as their disease worsens.” added Lisa Ricciardi, Cognition’s president and CEO. “Zervimesine showed meaningful impact across symptom domains including behavior, cognition, fluctuations, and motor function. This represents a clinically meaningful impact for DLB patients and their caregivers.”
The U.S. Food and Drug Administration (FDA) will meet Cognition during a Type C meeting scheduled for the second half of January 2026. During the meeting, the next clinical studies for zervimesine in DLB will be discussed, with a focus on clinically meaningful endpoints. Meeting minutes are expected to follow the Type C meeting.
Publication Citation:
Galvin JE, Tolea MI, Scharre DW, et al. Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB). Alzheimer's Dement. 2025; 21:e71004.
About the SHIMMER Study
The SHIMMER study (NCT05225415) was 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. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.
The SHIMMER study was supported by a grant award 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 clinical 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, 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), our clinical studies of zervimesine, analyses of the results from clinical studies and any expected or implied clinical benefits, expectations regarding development programs for zervimesine, and expectations that initial clinical results observed with respect to zervimesine will be replicated in later trials 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 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
FAQ
What were the key Phase 2 SHIMMER results for CGTX announced January 6, 2026?
How long was the zervimesine (CT1812) treatment in the CGTX Phase 2 DLB study?
What safety findings did Cognition report for CGTX zervimesine in DLB?
Did zervimesine improve neuropsychiatric symptoms in the CGTX trial?
What next steps did Cognition outline for CGTX and zervimesine in January 2026?
How many patients were randomized in the CGTX Phase 2 DLB study and where was it published?
