Early Data of Neflamapimod Showing Potential Benefit in Dementia With Lewy Bodies: John-Paul Taylor, MBBS, PhD, MRCPsych

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“As a clinician, one of the big things for me is that neflamapimod is an oral medication. The [adverse]-effect profile looks pretty good, and DLB is a population that is often quite frail. Having an oral medication that potentially offers disease-targeting elements is very intriguing and exciting.”

Neflamapimod (CervoMed) is an investigational, orally administered small-molecule inhibitor that crosses the blood–brain barrier and selectively targets the alpha isoform of p38 MAP kinase, a protein involved in neuroinflammatory processes and synaptic dysfunction. By modulating these pathways, neflamapimod is being evaluated for its potential effects on synaptic function and neuronal health. The agent is currently under clinical investigation for the treatment of dementia with Lewy bodies (DLB) in the phase 2b RewinD-LB trial (NCT05869669).¹

The initial phase of RewinD-LB was a 16-week, randomized, double-blind, placebo-controlled trial assessing neflamapimod in 159 participants with DLB, followed by a 32-week open-label extension in which all participants received neflamapimod. Participants with elevated plasma ptau181 at screening were excluded to enrich the population for individuals without Alzheimer disease co-pathology. The primary end point was change in the Clinical Dementia Rating–Sum of Boxes (CDR-SB). Secondary end points included the Alzheimer Disease Cooperative Study–Clinical Global Impression of Change (ADCS-CGIC), the Timed Up and Go test, and a cognitive test battery.

Researchers presented the full results of the phase 2b RewinD-LB study at the recently concluded 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, held December 1-4, 2025, in San Diego, California. Principal investigator John-Paul Taylor, MBBS, PhD, MRCPsych, professor of translational dementia research at Newcastle University, spoke with NeurologyLive^® at the conference to discuss the RewinD-LB trial evaluating neflamapimod in DLB. Taylor highlighted key considerations in trial design and outcome assessment, including the importance of measuring global symptom changes in this heterogeneous population. He also discussed aspects of the oral formulation and tolerability that may be particularly relevant for this patient population.

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REFERENCES
1. CervoMed Announces Late-Breaking Data at the 18th CTAD Conference Demonstrating Neflamapimod Significantly Slows Clinical Progression in Dementia with Lewy Bodies. News release. December 4, 2025. Accessed December 12, 2025. https://ir.cervomed.com/news-releases/news-release-details/cervomed-announces-late-breaking-data-18th-ctad-conference