Expanded Access Program For CT1812 (Zervimesine)

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/08/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Bradley Boeve, M.D.	Closed for enrollment	Contact information: Marissa Manthei 5072930906 manthei.marissa@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Boeve, M.D.

Closed for enrollment

Contact information:

Marissa Manthei

5072930906

manthei.marissa@mayo.edu

More information

Publications

The Dementia with Lewy Bodies (DLB) Consortium has refined its recommendations about the clinical and pathologic diagnosis of DLB, updating the previous report, which has been in widespread use for the last decade. The revised DLB consensus criteria now distinguish clearly between clinical features and diagnostic biomarkers, and give guidance about optimal methods to establish and interpret these. Substantial new information has been incorporated about previously reported aspects of DLB, with increased diagnostic weighting given to REM sleep behavior disorder and iodine-metaiodobenzylguanidine (MIBG) myocardial scintigraphy. The diagnostic role of other neuroimaging, electrophysiologic, and laboratory investigations is also described. Minor modifications to pathologic methods and criteria are recommended to take account of Alzheimer disease neuropathologic change, to add previously omitted Lewy-related pathology categories, and to include assessments for substantia nigra neuronal loss. Recommendations about clinical management are largely based upon expert opinion since randomized controlled trials in DLB are few. Substantial progress has been made since the previous report in the detection and recognition of DLB as a common and important clinical disorder. During that period it has been incorporated into DSM-5, as major neurocognitive disorder with Lewy bodies. There remains a pressing need to understand the underlying neurobiology and pathophysiology of DLB, to develop and deliver clinical trials with both symptomatic and disease-modifying agents, and to help patients and carers worldwide to inform themselves about the disease, its prognosis, best available treatments, ongoing research, and how to get adequate support. Read More on PubMed

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