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Randomized, double-blind study of zervimesine in mild to moderate Alzheimer's disease
Everard G B Vijverberg, Douglas W Scharre, Michael Woodward, Susan Catalano, Mary E Hamby, Michael Grundman, Roger E Morgan, Jennifer Iaci et al.. Journal of Alzheimer's disease : JAD, 2026-04-03
Topic: Drug trials: efficacy and safety
BackgroundZervimesine (CT1812) is a first-in-class, brain-penetrant sigma-2 receptor ligand that prevents binding and displaces Aβ42 oligomers from receptors on neuronal synapses.ObjectiveThis study evaluated the safety and efficacy of zervimesine in mild to moderate Alzheimer's disease (AD).MethodsThis was a Phase 2, randomized, double-blind, placebo-controlled study. Participants were randomized to zervimesine 100 mg or 300 mg or placebo. In addition to ADAS-Cog11, outcomes were evaluated from baseline plasma p-tau217 in prespecified subgroups.ResultsOf 153 adults randomized, 150 were included in the mITT population. Adverse events occurred in 70.6% with zervimesine 100 mg, 82.4% with zervimesine 300 mg, and 78.0% with placebo. At Day 182, the ADAS-Cog 11 increased from baseline (indicating a decline in cognitive function) with the LS mean (SE) change of 2.69 (0.81) points in the placebo group versus 1.66 (0.60) points in the pooled zervimesine group [δ = -1.03 (-3.01, 0.96), p = 0.310]. For participants with baseline plasma p-tau217 levels below the median (1.0 pg/mL), the pooled zervimesine group showed greater improvement on the ADAS-Cog 11 at Day 182 relative to placebo (δ = -2.66; p = 0.080).ConclusionsThis phase 2 study indicated that zervimesine was safe and well tolerated and showed consistently favorable numerical treatment differences versus placebo. More robust treatment differences were observed in the below median baseline plasma p-tau217 group suggesting potentially greater efficacy of zervimesine in less advanced AD. These results support larger pivotal trials with zervimesine.Registered at clinicaltrials.gov: NCT03507790.
Key findings
- At Day 182, the ADAS-Cog 11 increased from baseline (indicating a decline in cognitive function) with the LS mean (SE) change of 2.69 (0.81) points in the placebo group versus 1.66 (0.60) points in the pooled zervimesine group [δ = -1.03 (-3.01, 0.96), p = 0.310].
- For participants with baseline plasma p-tau217 levels below the median (1.0 pg/mL), the pooled zervimesine group showed greater improvement on the ADAS-Cog 11 at Day 182 relative to placebo (δ = -2.66; p = 0.080).ConclusionsThis phase 2 study indicated that zervimesine was safe and well tolerated and showed consistently favorable numerical treatment differences versus placebo.
- These results support larger pivotal trials with zervimesine.Registered at clinicaltrials.gov: NCT03507790.
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Study details
- Study designclinical trial
- Participants153
- Effect size70.6%; 82.4%; 78.0%
- Evidence strengthHigh
How this study scored 86/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and free to read, so those were left out: it earned 51 of the 59 points we could judge it on, which is 86 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Alzheimer's disease : JAD) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| 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 | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 2 / 4 | 153 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) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41930592) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 51 / 59 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 51 of the 59 points we could judge it on is 86 out of 100. |
| Total | 86 / 100 | — |
What each of these 20 components measures, and what this score is not →
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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APA 7th
Vijverberg, E. G. B., Scharre, D. W., Woodward, M., Catalano, S., Hamby, M. E., Grundman, M., et al. (2026). Randomized, double-blind study of zervimesine in mild to moderate Alzheimer's disease. Journal of Alzheimer's disease : JAD. https://doi.org/10.1177/13872877261437145
Vancouver
Vijverberg EGB, Scharre DW, Woodward M, Catalano S, Hamby ME, Grundman M, et al. Randomized, double-blind study of zervimesine in mild to moderate Alzheimer's disease. Journal of Alzheimer's disease : JAD. 2026. doi:10.1177/13872877261437145. PMID: 41930592.
BibTeX
@article{vijverberg2026-41930592,
author = {Vijverberg, Everard G B and Scharre, Douglas W and Woodward, Michael and Catalano, Susan and Hamby, Mary E and Grundman, Michael and Morgan, Roger E and Iaci, Jennifer and others},
title = {{Randomized, double-blind study of zervimesine in mild to moderate Alzheimer's disease}},
journal = {Journal of Alzheimer's disease : JAD},
year = {2026},
doi = {10.1177/13872877261437145},
pmid = {41930592},
url = {https://doi.org/10.1177/13872877261437145}
}
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