Neflamapimod Trial Misses Primary Endpoint for Lewy Bodies
The drug failed to show cognitive improvement in a phase 2b trial for patients with dementia with Lewy bodies.
Updated on Oct. 29, 2026 in Alzheimer’s
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Neflamapimod failed to improve clinical dementia scores in a phase 2b trial of 159 patients with probable dementia with Lewy bodies. While the drug did not meet its primary endpoint, exploratory analyses suggest potential benefits for specific patient subgroups with lower levels of Alzheimer disease copathology.
Why it matters
The study sought to determine if inhibiting p38 alpha kinase could treat dementia with Lewy bodies, a condition currently lacking specialized therapies. The findings provide critical insights into how the drug may perform depending on the presence of comorbid Alzheimer pathology.
In the 16-week study of 159 patients, neflamapimod was administered at a 40 mg dosage three times daily. Discontinuation rates due to adverse events reached 2.5 percent in the treatment group compared to 1.3 percent in the placebo cohort.
The players
CervoMed
The pharmaceutical company is developing neflamapimod as a potential treatment for neurodegenerative conditions like dementia with Lewy bodies.
The details
Researchers excluded patients with plasma pTau181 levels of 27.2 pg/mL or higher to isolate the effects of the treatment on Lewy body dementia. The drug, which inhibits interleukin-1 beta signaling pathways, achieved a mean trough plasma concentration of 4.15 ng/mL.
Timeline
The RewinD-LB trial results were published on October 20, 2026.
CervoMed issued a press release detailing the study findings on October 29, 2026.
The Big Picture
This study is part of the broader effort to address unmet needs in dementia with Lewy bodies by targeting specific inflammatory pathways. The results contribute to the ongoing evaluation of neflamapimod as a novel therapeutic candidate in neurodegenerative research.
The results of this trial do not change current treatment options for patients with Lewy body dementia, as the medication is not yet approved for clinical use. Families should consult with their healthcare providers regarding ongoing clinical trials or established care routines.
The takeaway
While the phase 2b study failed to meet its primary objective, the identification of benefit in specific subgroups offers a potential path forward for researchers. Future trials will focus on whether higher dosing regimens can successfully achieve measurable cognitive improvements.
What happens next
CervoMed plans to initiate a phase 3 clinical trial for neflamapimod utilizing a new 100 mg twice-daily dosage regimen.
Further reading
For additional context on current research, visit our Alzheimer’s section.
More information
Read the full CervoMed press release on clinical trial.
Source note: This article includes information reported by Psychiatrictimes.
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