Experimental drug zervimesine made available to patients with lewy body dementia
NCT ID NCT06961760
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This expanded access program offers the experimental drug zervimesine (CT1812) to people aged 50 to 86 with mild-to-moderate dementia with Lewy bodies. Participants take one 100 mg pill daily for up to a year. The goal is to provide access to the drug and collect long-term safety information.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zervimesine (CT1812)
- What this could lead to
- If this program shows that zervimesine is safe and well-tolerated over a year, it could support further research into a treatment for dementia with Lewy bodies.
- What could go wrong
- This is an expanded access program, not a formal trial, so it provides limited evidence of effectiveness. The drug is still experimental, and long-term risks are not fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 86 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
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Columbia University Medical Center
New York, New York, 10032, United States
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
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Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, 43210, United States
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Stanford Neuroscience Heath Center
Palo Alto, California, 94304, United States
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Summit Headlands LLC
Portland, Oregon, 97210, United States
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University of Colorado Denver - Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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University of Miami - Department of Neurology
Boca Raton, Florida, 33433, United States
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