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Expanded Access Program for CT1812 (Zervimesine)

A Single-arm, Open-label, Expanded Access Program to Provide 100 mg CT1812 (Zervimesine) and to Collect Long-term Safety and Efficacy Data in Participants With Mild-to-moderate Dementia With Lewy Bodies (DLB).

Asset

CT1812

Listed sites

8

Recruiting sites

-

Enrollment

-

Study population

Lewy body dementia

Key I/E criteria

Dementia with Lewy bodiesMMSE 18-27Study partner/caregiver required

Primary endpoint

-

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCOG1202
NCT IDNCT06961760

Timeline

Milestones

Study first posted2025-05-08actual
Last update posted2026-05-28actual

Assets

Drug assets

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years
Maximum age86 Years
SexAll

Inclusion criteria

1. Participants must meet either one of the following criteria:

1. Randomized participant in protocol COG1201 and completed the study or

2. Referred by their treating physician to a participating COG1202 study site with a confirmed diagnosis of probable 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

2. 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.

3. Men or women 50- 86 years of age (inclusive).

4. Must have had no clinically relevant findings, other than change for progression of DLB, on historical MRI or CT scan.

5. In the opinion of the investigator, must be able to complete all protocol evaluations

Exclusion criteria

1. 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.

2. Any neurological condition that may be contributing to cognitive impairment and beyond those caused by the participant's DLB.

3. 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.

4. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.

5. Any condition, which in the opinion of the investigator or the sponsor makes the participant unsuitable for inclusion.

6. No access to a Primary Care Physician, inability or unwillingness to have lab sample collection completed per protocol.

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.