PURCHASE, N.Y. — November 13, 2025 — Leads & Copy — Cognition Therapeutics, Inc., a clinical-stage company focused on developing drugs for neurodegenerative disorders, has completed target enrollment of 540 participants in its Phase 2 ‘START’ Study, which is randomized and placebo-controlled.
The START study is assessing the safety and activity of zervimesine (CT1812) in individuals with mild cognitive impairment (MCI) or early Alzheimer’s disease. Topline results are expected after all participants complete 18 months of treatment.
According to Lisa Ricciardi, Cognition’s president and CEO, the clinical operations teams have driven impressive enrollment numbers this year, with approximately 50% of the study population enrolled during the last six months. Ricciardi also noted the strong interest from patients and investigators, and the presentations of Phase 2 results in mild-to-moderate Alzheimer’s disease and dementia with Lewy bodies (DLB) at international conferences.
The START study was initiated shortly after Leqembi was granted accelerated approval in the U.S. Cognition and ACTC decided to allow individuals on stable background therapy with an approved monoclonal antibody therapy to participate. Around 15% of participants randomized into START were also receiving infusions of 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, said that it’s an exciting time to be involved in Alzheimer’s disease research, with two approved anti-amyloid antibodies, many patients now have new treatment options. He added that the START study was a unique opportunity to investigate an experimental oral drug with a mechanism unlike that of the currently approved immunotherapeutics, potentially treating a broader segment of the Alzheimer’s patient community.
Anthony O. Caggiano, Cognition’s chief medical officer, expects zervimesine’s oral dosing and safety profile, without increased risk of ARIA or need for serial imaging, to reduce the burden on patients and healthcare providers. Caggiano also believes 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.
The START Study (NCT05531656) is designed to measure the efficacy and tolerability of once-daily oral zervimesine in individuals with MCI or early Alzheimer’s disease who have elevated Aβ, as measured by PET or CSF. Participants are randomized to receive zervimesine or a 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 clinical trial network of 35 leading academic sites.
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). It may be able to slow the progression of disease and improve the lives of those suffering from Alzheimer’s and DLB. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.
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. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com.
Contact Information:
Cognition Therapeutics, Inc.
info@cogrx.com
Mike Moyer (investors)
LifeSci Advisors
mmoyer@lifesciadvisors.com
Source: Cognition Therapeutics, Inc.
Source: Cognition Therapeutics, Inc.
