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A Phase 2b randomized clinical trial of the oral p38α inhibitor neflamapimod in dementia with Lewy bodies (DLB)
Taylor J, Alam JJ, Gomperts SN, Honig LS, Prins ND, Koubiyr I, Chu H, Gardner A et al.. Research Square, 2026-08-14
Topic: Brain proteins, microglia and lab models
Abstract Background: There is high unmet need in dementia with Lewy bodies (DLB). Neflamapimod, showed clinical activity against cognitive and motor endpoints at a dose of 40mg three-times-daily (TID) in a prior phase 2a study in DLB, most prominently in those without Alzheimer disease (AD) co-pathology, assessed by plasma ptau181. Methods: 16-week randomized, placebo-controlled clinical trial, with a 32-week open label extension, conducted at 43 centers in the US, UK and Netherlands. 159 participants with probable DLB by consensus criteria, screened to enrich for patients without AD co-pathology (plasma ptau181≥27.2 pg/mL excluded), randomized between August 2023 and June 2024 to neflamapimod 40mg (80 participants) or matching placebo (79 participants) capsules, TID.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Taylor, J., Alam, J. J., Gomperts, S. N., Honig, L. S., Prins, N. D., Koubiyr, I., et al. (2026). A Phase 2b randomized clinical trial of the oral p38α inhibitor neflamapimod in dementia with Lewy bodies (DLB). Research Square. https://doi.org/10.21203/rs.3.rs-10623740/v1
Vancouver
Taylor J, Alam JJ, Gomperts SN, Honig LS, Prins ND, Koubiyr I, et al. A Phase 2b randomized clinical trial of the oral p38α inhibitor neflamapimod in dementia with Lewy bodies (DLB). Research Square. 2026. doi:10.21203/rs.3.rs-10623740/v1.
BibTeX
@article{taylor2026-9c23dcf2,
author = {Taylor, J. and Alam, J. J. and Gomperts, S. N. and Honig, L. S. and Prins, N. D. and Koubiyr, I. and Chu, H. and Gardner, A. and others},
title = {{A Phase 2b randomized clinical trial of the oral p38α inhibitor neflamapimod in dementia with Lewy bodies (DLB)}},
journal = {Research Square},
year = {2026},
doi = {10.21203/rs.3.rs-10623740/v1},
url = {https://doi.org/10.21203/rs.3.rs-10623740/v1}
}
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's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
Key findings
- Neflamapimod, showed clinical activity against cognitive and motor endpoints at a dose of 40mg three-times-daily (TID) in a prior phase 2a study in DLB, most prominently in those without Alzheimer disease (AD) co-pathology, assessed by plasma ptau181.
- Methods: 16-week randomized, placebo-controlled clinical trial, with a 32-week open label extension, conducted at 43 centers in the US, UK and Netherlands. 159 participants with probable DLB by consensus criteria, screened to enrich for patients without AD co-pathology (plasma ptau181≥27.2 pg/mL excluded), randomized between August 2023 and June 2024 to neflamapimod 40mg (80 participants) or matching placebo (79 participants) capsules, TID.
- Primary outcome measure: change in Clinical Dementia Rating Sum-of-Boxes (CDR-SB).
- Secondary outcome measures: Timed up and Go test, ADCS Clinical Global Impression of Change, and a study-specific cognitive test battery.
Why it matters
This 16-week randomized placebo-controlled trial with a 32-week open label extension tested the oral p38α inhibitor neflamapimod in 159 people with probable dementia with Lewy bodies, enriched for those without Alzheimer's disease co-pathology. It concerns dementia with Lewy bodies, not Alzheimer's disease, so it does not show a way to treat, cure, or prevent Alzheimer's disease.
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Study details
- Participants159
- Effect size85.6%; 2.5%; 1.3%
- Evidence strengthHigh
How this study scored 16/100
Preprint — not yet peer-reviewed. It scored 37 on the same rubric, but non-peer-reviewed sources are capped at 16, so it shows as 16. Scored zero for study design because the record does not state it. We have no data on impact for its field and year, so that was left out: it earned 35 of the 94 points we could judge it on, which is 37 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 2 / 10 | Tier 4 — not a peer-reviewed journal (Research Square) |
| Journal's citation record | 0 / 4 | Not a journal article, so the journal's record does not count |
| 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 | 4 / 10 | Preprint — not yet peer-reviewed. Hosted on a preprint server. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 2 / 4 | 159 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 | 1 / 7 | Cited 1 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.5 citations a year over 2 year(s) since 2026 |
| 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 | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 1 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author James E. Galvin: h-index 56 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Massachusetts General Hospital: institution h-index 2,057 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | OpenAlex lists 7 institution(s) in 3 countries |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 2 / 2 | Free to read |
| Points | 35 / 94 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 35 of the 94 points we could judge it on is 37 out of 100. |
| Total | 37 / 100 | Capped to 16 because this is not a peer-reviewed article. |
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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