Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Reaches 75% Enrollment Target
Cognition Therapeutics (NASDAQ: CGTX) announced that its Phase 2 'START' Study for zervimesine (CT1812) has achieved 75% enrollment of its target 540 participants with mild cognitive impairment (MCI) and early Alzheimer's disease. The study, conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) and funded by the National Institute of Aging, will evaluate the drug against placebo over an 18-month treatment period.
The company previously reported positive results from its SHINE Study in 2024, which demonstrated that zervimesine slowed cognitive deterioration in mild-to-moderate Alzheimer's patients with lower p-tau217 levels. The START Study aims to evaluate the drug's efficacy in earlier disease stages.
Cognition Therapeutics (NASDAQ: CGTX) ha annunciato che lo studio di fase 2 "START" su zervimesine (CT1812) ha raggiunto il 75% dell'arruolamento previsto, su un target di 540 partecipanti con compromissione cognitiva lieve (MCI) e primi stadi di Alzheimer. Lo studio, condotto in collaborazione con l'Alzheimer's Clinical Trials Consortium (ACTC) e finanziato dal National Institute on Aging, confronterà il farmaco con il placebo durante un periodo di trattamento di 18 mesi.
L'azienda aveva già riportato risultati positivi dallo studio SHINE nel 2024, in cui zervimesine ha rallentato il declino cognitivo in pazienti con Alzheimer da lieve a moderato con livelli più bassi di p-tau217. Lo studio START mira ora a valutarne l'efficacia nelle fasi più precoci della malattia.
Cognition Therapeutics (NASDAQ: CGTX) anunció que su estudio de fase 2 "START" para zervimesine (CT1812) ha alcanzado el 75% de la inscripción prevista, sobre un objetivo de 540 participantes con deterioro cognitivo leve (MCI) y Alzheimer en fases tempranas. El estudio, realizado en colaboración con el Alzheimer's Clinical Trials Consortium (ACTC) y financiado por el National Institute on Aging, evaluará el fármaco frente a placebo durante un periodo de tratamiento de 18 meses.
La compañía informó previamente resultados positivos de su estudio SHINE en 2024, que mostraron que zervimesine ralentizó el deterioro cognitivo en pacientes con Alzheimer leve a moderado con niveles más bajos de p-tau217. El estudio START pretende evaluar ahora la eficacia del fármaco en etapas más tempranas de la enfermedad.
Cognition Therapeutics (NASDAQ: CGTX)는 제르비메신(zervimesine, CT1812) 대상의 2상 'START' 연구가 경도인지장애(MCI) 및 초기 알츠하이머 환자 540명을 목표로 75% 등록 완료했다고 발표했습니다. 이 연구는 알츠하이머 임상시험 컨소시엄(ACTC)과 협력하고 국립노화연구소(National Institute on Aging)의 자금을 받아, 18개월 치료 기간 동안 약물을 위약과 비교 평가합니다.
회사는 2024년 SHINE 연구에서 제르비메신이 p-tau217 수치가 낮은 경증~중등도 알츠하이머 환자의 인지 저하를 늦춘다는 긍정적 결과를 보고한 바 있습니다. START 연구는 질환의 더 초기 단계에서 약물의 효능을 평가하는 것을 목표로 합니다.
Cognition Therapeutics (NASDAQ: CGTX) a annoncé que son étude de phase 2 « START » sur la zervimesine (CT1812) a atteint 75 % du recrutement visé, sur un total prévu de 540 participants présentant un trouble cognitif léger (MCI) et des stades précoces de la maladie d'Alzheimer. L'étude, menée en collaboration avec l'Alzheimer's Clinical Trials Consortium (ACTC) et financée par le National Institute on Aging, comparera le médicament au placebo pendant une période de traitement de 18 mois.
La société avait déjà publié des résultats positifs de l'étude SHINE en 2024, montrant que la zervimesine ralentissait la détérioration cognitive chez des patients atteints d'Alzheimer léger à modéré présentant des niveaux plus faibles de p‑tau217. L'étude START vise désormais à évaluer l'efficacité du médicament à des stades plus précoces de la maladie.
Cognition Therapeutics (NASDAQ: CGTX) gab bekannt, dass seine Phase‑2‑Studie "START" zu Zervimesine (CT1812) 75% der Zielrekrutierung erreicht hat; Ziel sind 540 Teilnehmende mit leichter kognitiver Beeinträchtigung (MCI) und frühem Alzheimer. Die Studie, durchgeführt in Zusammenarbeit mit dem Alzheimer's Clinical Trials Consortium (ACTC) und finanziert vom National Institute on Aging, wird das Medikament über einen 18‑monatigen Behandlungszeitraum gegen Placebo prüfen.
Das Unternehmen hatte bereits 2024 positive Ergebnisse der SHINE‑Studie berichtet, in der Zervimesine den kognitiven Abbau bei Patienten mit leichtem bis mittelschwerem Alzheimer und niedrigeren p‑tau217‑Werten verlangsamte. Die START‑Studie soll nun die Wirksamkeit in früheren Krankheitsstadien untersuchen.
- None.
- Phase 2 trial still requires completion of remaining 25% enrollment
- Results from the START Study are not yet available
PURCHASE, N.Y., Sept. 03, 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 Phase 2 ‘START’ Study has reached the
“We believe the strong enrollment pace in the START Study is due to interest on the part of patients and investigators in the potential of a convenient, once-daily oral medication,” stated Lisa Ricciardi, Cognition’s president and CEO. “The START Study is our largest Phase 2 trial to date and our second in Alzheimer’s disease. In 2024 we reported results from the SHINE Study in patients with mild-to-moderate Alzheimer's disease, which showed zervimesine slows cognitive deterioration in patients with lower levels of p-tau217. In the START study, we are testing zervimesine in people at earlier stages of disease progression. We look forward to building an understanding of zervimesine’s potential across the Alzheimer’s spectrum.”
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 assess cognition and executive function using validated tools including the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales, as well as biomarker and safety findings.
The START Study is supported by an
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 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, 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 and our expectations regarding the 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 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 is the enrollment status of Cognition Therapeutics' (CGTX) START Study for zervimesine?
How long will participants be treated in the CGTX START Study?
What were the results of Cognition Therapeutics' previous SHINE Study?
Who is funding the Cognition Therapeutics START Study?
What type of medication is zervimesine (CT1812)?
