ClinicalTrials.gg
No longer availableNCT06961760Updated May 28, 2026

Expanded Access Program for CT1812 (Zervimesine)

An expanded access record providing zervimesine in Dementia With Lewy Bodies, sponsored by Cognition Therapeutics. No longer available at 8 sites in United States. Open to participants aged 50 Years to 86 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Cognition Therapeutics · Expanded access

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Study type
Expanded access
Access type
Intermediate-size population
Ages
50 Years to 86 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 110 studies in Lewy Body Disease with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Lewy Body Disease · United States.

Other kind
Only one
of the 110
Registered
99th of 110
by date

Among the 110 studies in Lewy Body Disease with a site in United States, this one is the only one of another kind, and was the 99th registered.

Lewy Body Disease

239 studies on the registry are indexed under Lewy Body Disease; 88 are open to participants now.

Browse Lewy Body Disease studies →

Open to participants now

32 of the 110 studies in Lewy Body Disease with a site in United States are open now. Recruiting first, the newest first:

27 more — sign in →

All 32 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 63 Lewy Body Disease studies recruiting now, 41 (65%) set no upper age limit and none (0%) stop at 75 or younger; 10 take children under 18; 31 take healthy volunteers.

This study: 50 Years to 86 Years · all sexes.

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02

Study 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.

Read the detailed description

Participants will be screened for eligibility by physical, laboratory, and select psychometric and neurologic assessments. Participants, after having met all inclusion criteria, and none of the exclusion criteria, will be enrolled. The first dose will be taken in the clinic. Participants and their caregivers/study partner will have a study visit clinic for repeat psychometric/neurologic testing, safety procedures and lab sample collection. Each participant and caregiver/study partner will participate in a screening period of up to 7 days, followed by an open label treatment period of 720 (± 4 days) days and a follow up phone call at day 750 (± 4 days) for a maximum of 757 days of study participation including screening.

03

Conditions studied

  • Dementia With Lewy Bodies

Keywords

  • Dementia
04

Who can participate

Ages eligible
50 Years to 86 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 () 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 to participate in the study.
  3. Men or women 50- 86 years of age (inclusive).
  4. Must have had no 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

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- prostate cancer that has been stable for at least 6 months based on imaging or Prostate-Specific Antigen (PSA) levels.
  4. , 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • Zervimesine (CT1812) was shown to be safe and well tolerated in a study of healthy volunteers and in Phases 1 and 2 studies of participants with mild to moderate AD and DLB. This is an open label expanded access program designed to provide access to CT1812 and to evaluate the long-term safety of CT1812 administered once daily in adults aged 50 to 86 who have been diagnosed with mild to moderate DLB (the targeted clinical indication for CT1812). Participants will receive 100 mg of CT1812 once daily for the entire study.

    Also known as: CT1812

06

Where to request access

8 sites
  • Banner Sun Health Research Institute
    Sun City, Arizona 85351, United States
  • Stanford Neuroscience Heath Center
    Palo Alto, California 94304, United States
  • University of Colorado Denver - Anschutz Medical Campus
    Aurora, Colorado 80045, United States
  • University of Miami - Department of Neurology
    Boca Raton, Florida 33433, United States
  • Mayo Clinic - Rochester
    Rochester, Minnesota 55905, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Ohio State University Wexner Medical Center (OSUWMC)
    Columbus, Ohio 43210, United States
  • Summit Headlands LLC
    Portland, Oregon 97210, United States
07

References and documents

Publications

  • McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7. PubMed 28592453 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06961760
Lead sponsor
Cognition Therapeutics
Responsible party
Sponsor
First posted
May 8, 2025
Last update
May 28, 2026

Study contacts

Anthony Caggiano, PHD
study director · Cognition Therapeutics Inc.
View the source record on ClinicalTrials.gov ↗

Requesting access

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No contact was published for this record. The registry link below has the sponsor’s details.

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