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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. Alzheimer s & Dementia, 2025-12-01
Topic: Brain proteins, microglia and lab models
Plain-language summary
Of 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. 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.
What this study adds
Evidence grade: High
The record lists 293 participants. In this phase 2 trial, 130 participants with mild-to-moderate dementia with Lewy bodies were randomized, and zervimesine was found to be safe and well tolerated, with favorable trends on exploratory endpoints. Reported effect size: 83.8%; 4.5%; 16.3%.
Taken from this record’s own fields, not from reading the paper. The grade is assigned from the abstract’s wording; what that means.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Galvin, J. E., Tolea, M. I., Scharre, D. W., Hamby, M. E., Iaci, J. F., Grundman, M., et al. (2025). Phase 2 study of zervimesine (CT1812) in participants with mild‐to‐moderate dementia with Lewy bodies (DLB). Alzheimer s & Dementia. https://doi.org/10.1002/alz.71004
Vancouver
Galvin JE, Tolea MI, Scharre DW, Hamby ME, Iaci JF, Grundman M, et al. Phase 2 study of zervimesine (CT1812) in participants with mild‐to‐moderate dementia with Lewy bodies (DLB). Alzheimer s & Dementia. 2025. doi:10.1002/alz.71004. PMID: 41416579.
BibTeX
@article{galvin2025-41416579,
author = {Galvin, James E. and Tolea, Magdalena I. and Scharre, Douglas W. and Hamby, Mary E. and Iaci, Jennifer F. and Grundman, Michael and Caggiano, Anthony O.},
title = {{Phase 2 study of zervimesine (CT1812) in participants with mild‐to‐moderate dementia with Lewy bodies (DLB)}},
journal = {Alzheimer s \& Dementia},
year = {2025},
doi = {10.1002/alz.71004},
pmid = {41416579},
url = {https://doi.org/10.1002/alz.71004}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
Key findings
- Of 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.
- 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.
Why it matters
In this phase 2 trial, 130 participants with mild-to-moderate dementia with Lewy bodies were randomized, and zervimesine was found to be safe and well tolerated, with favorable trends on exploratory endpoints. The authors state these results provide a rationale for testing zervimesine in larger studies, so efficacy for treating the disease is not yet established.
Study details
- Participants293
- Effect size83.8%; 4.5%; 16.3%
- Evidence strengthHigh
How this study scored 53/100
Published in a peer-reviewed journal. Scored zero for study design because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 51 of the 96 points we could judge it on, which is 53 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer s & Dementia) |
| Journal's citation record | 2 / 4 | Alzheimer s & Dementia: journal h-index 228 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 293 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 1 / 2 | Randomized (as stated in the record) |
| Times cited | 2 / 7 | Cited 6 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 2.0 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 3 / 6 | Cited 3.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 6 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 2 / 3 | University of California San Diego: institution h-index 1,852 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41416579) |
| Free to read | 2 / 2 | Free to read |
| Points | 51 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 51 of the 96 points we could judge it on is 53 out of 100. |
| Total | 53 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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