Expanded Access Program for CT1812 (Zervimesine)

NCT06961760 | Unknown

• 1 other identifier: COG1202
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multi-center, open label, expanded access program (EAP) that will provide 100 mg CT1812 for up to one year to participants with mild-to-moderate DLB.

Conditions

Dementia With Lewy Bodies

Keywords

Dementia

Interventions

zervimesine DRUG

Zervimesine (CT1812) was shown to be safe and well tolerated in a study of healthy volunteers and in Phases 1 and 2 studies of participants with mild to moderate AD and DLB. This is an open label expanded access program designed to provide access to CT1812 and to evaluate the long-term safety of CT1812 administered once daily for 12 months in adults aged 50 to 86 who have been diagnosed with mild to moderate DLB (the targeted clinical indication for CT1812). Participants will receive 100 mg of CT1812 once daily for 360 days.

Also known as: CT1812

Eligibility Criteria

• Age: 50 Years - 86 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet either one of the following criteria:
• Randomized participant in protocol COG1201 and completed the study or
• Referred by their treating physician to a participating COG1202 study site with a confirmed diagnosis of DLB, provide evidence of a historical MRI (within last 3 months) or CT-Scan (within last 3 months), a baseline Mini Mental Status Examination score (MMSE) of 18 - 27 inclusive and be approved by Sponsor
• Participants must have caregiver(s) / study partner who in the opinion of the site principal investigator, has contact with the study participant for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and willing and able to participate in study visits and some study assessments. The caregiver/ study partner must also provide informed consent to participate in the study.
• Men or women 50- 86 years of age (inclusive).
• Must have had no clinically relevant findings, other than change for progression of DLB, on historical MRI or CT scan.
• In the opinion of the investigator, must be able to complete all protocol evaluations.

You may not qualify if:

• If enrolled in the previous CT1812 clinical trial for DLB (COG1201), did not complete the clinical trial, or had an adverse event that could cause an undue risk, or progressed to severe DLB and cannot complete study assessments.
• Any neurological condition that may be contributing to cognitive impairment and beyond those caused by the participant's DLB.
• History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months based on imaging or Prostate-Specific Antigen (PSA) levels.
• Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
• No access to a Primary Care Physician, inability or unwillingness to have lab sample collection completed per protocol.

Sponsors & Collaborators

• Cognition Therapeutics: lead

Study Sites (8)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Stanford Neuroscience Heath Center

Palo Alto, California, 94304, United States

Location

University of Colorado Denver - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Miami - Department of Neurology

Boca Raton, Florida, 33433, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Ohio State University Wexner Medical Center (OSUWMC)

Columbus, Ohio, 43210, United States

Location

Summit Headlands LLC

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Lewy Body Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anthony Caggiano, PHD

  Cognition Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (8)