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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).
Lead sponsor
Asset
CT1812
Listed sites
8
Recruiting sites
-
Enrollment
-
Study population
Lewy body dementia
Key I/E criteria
•Dementia with Lewy bodies•MMSE 18-27•Study 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Registry references + supporting bibliography
- PMID28592453via BACKGROUND
Provenance
Sources
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.