Expanded Access Program for CT1812 (Zervimesine) (NCT06961760) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Expanded Access Program for CT1812 (Zervimesine)
United States
Plain-language 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.
Who can participate
Age range
50 Years – 86 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 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
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Any condition, which in the opinion of the investigator or the sponsor makes the participant unsuitable for inclusion.
. No access to a Primary Care Physician, inability or unwillingness to have lab sample collection completed per protocol.