Evidence map›Paper›PMID 41416579›Full record

Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2025

Phase 2 study of zervimesine (CT1812) in participants with mild-to-moderate dementia with Lewy bodies (DLB).

James E Galvin, Magdalena I Tolea, Douglas W Scharre, Mary E Hamby, Jennifer F Iaci, Michael Grundman, Anthony O Caggiano

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05225415 (A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05225415 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies

TypeinterventionalSponsorCognition TherapeuticsRan2022 to 2024Enrolled130ConditionsDementia With Lewy BodiesArmsCT1812
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Phase 2 study of zervimesine (CT1812) in participants with mild-to-moderate dementia with Lewy bodies (DLB).Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

James E GalvinLewy Body Dementia Research Center of Excellence, Department of Neurology, University of Miami Miller School of Medicine, Boca Raton, Florida, USA.
Magdalena I ToleaLewy Body Dementia Research Center of Excellence, Department of Neurology, University of Miami Miller School of Medicine, Boca Raton, Florida, USA.
Douglas W ScharreDivision of Cognitive Neurology, Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Mary E HambyCognition Therapeutics, Inc., Pittsburgh, Pennsylvania, USA.
Jennifer F IaciCognition Therapeutics, Inc., Pittsburgh, Pennsylvania, USA.
Michael GrundmanGlobal R&D Partners, LLC, San Diego, California, USA.
Anthony O CaggianoCognition Therapeutics, Inc., Pittsburgh, Pennsylvania, USA.

Funding

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy BodiesR01AG071643 · NIA · COGNITION THERAPEUTICS, INC. · PI CAGGIANO, ANTHONY O, GALVIN, JAMES E · 2021 to 2023
$29.5M
NIA NIH HHS R01 AG071643SHIMMER NCT05225415
6 · The paper itself

Abstract

introductionZervimesine is in clinical development for Alzheimer's disease and dementia with Lewy bodies (DLB). This Phase 2a study evaluated zervimesine in participants with mild-to-moderate DLB.

methodsThis was a multi-center, double-blind, placebo-controlled, parallel-design study. Participants aged 50 to 85 years, with probable DLB, a Mini-Mental State Examination score of 18 to 27, and without neurological co-morbidities were randomized to zervimesine 100 mg, zervimesine 300 mg, or placebo for 26 weeks to assess safety and efficacy.

resultsOf 293 participants screened, 130 were randomized, and 109 (83.8%) completed the study. Baseline characteristics were similar between groups. Discontinuation rates for adverse events were 4.5% for zervimesine 100 mg, 16.3% for zervimesine 300 mg, and 4.8% for placebo. DISCUSSION: This study demonstrated that zervimesine was safe and well tolerated. The favorable efficacy profile from exploratory outcomes provides a rationale for testing zervimesine in larger studies. This study was registered at ClinicalTrials.gov: NCT05225415. HIGHLIGHTS: This study evaluated the safety and efficacy of zervimesine in Lewy body dementia. The incidence of adverse events was comparable to zervimesine 100 mg and placebo. Favorable, consistent trends were observed with zervimesine for exploratory endpoints.

Indexed as

Lewy Body DiseaseAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMental Status and Dementia TestsMiddle AgedTreatment OutcomeCT1812efficacyLewy body dementiasafetyzervimesine

Identifiers

PMID41416579
PMCPMC12715698

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.