March 19, 2025
Earlier this month, CervoMed Pharmaceuticals reported data from an open-label extension phase of the RewinD-LB trial suggesting that the study drug, neflamapimod, may slow cognitive decline in dementia with Lewy bodies (DLB).
What was the RewinD-LB trial?
RewinD-LB was a Phase 2b trial of the experimental drug neflamapimod in people with DLB. A prior Phase 2a trial showed benefit on cognitive decline, particularly for people without evidence of co-existing Alzheimer’s disease (AD). The RewinD-LB trial sought to replicate the findings of the earlier trial, but focused only on people with DLB and no evidence of AD.
In the main phase of RewinD-LB, researchers did not find the same kinds of positive results as they did in the original trial. However, the researchers learned that the drug capsules used in the main phase of the trial were not delivering the same level of drug as they did in the prior Phase 2a trial, possibly explaining the discrepancy in findings.
After the main phase of RewinD-LB, all participants were offered a chance to take the study drug in a phase of the trial called an open-label extension. In the extension phase, all volunteers take active drug; there is no placebo group. The open-label extension is scheduled to last for 32 weeks, and the researchers are now reporting results from the halfway point – 16 weeks.
What are we learning from the extension phase?
During the first 16 weeks of the extension phase, some volunteers took the same capsules as used in the main phase. These are the “old” capsules. Other volunteers took new capsules that delivered the expected amount of the study drug – “new” capsules.
Measures of cognition were repeated at the 16-week time point. Volunteers who were taking the “old” capsules continued to worsen. But for volunteers taking the “new” capsules, the worsening was markedly slowed, suggesting that the study drug is effective at slowing cognitive and functional decline when delivered at the intended dose level. When measuring from the beginning of the main phase of the study, volunteers taking “old” capsules had a worsening of approximately 1.5 points on the Clinical Dementia Rating Scale – Sum of the Boxes (CDR-SB) through the first 16 weeks of the extension phase, whereas volunteers taking the “new” capsules declined by only approximately 0.7 points.
What is next for this study?
While the results through the halfway point of the extension phase look quite promising, the full extension will last 32 weeks, and all volunteers have now been switched to the “new” capsules for the remainder of the extension. At the end of the 32 weeks, cognitive and functional measures will be repeated. In addition, biomarker testing will be repeated at the end of the extension phase (it was not done at the 16-week point).
Scientists are eagerly awaiting the results of the full extension phase; the additional data will help to place the current results in context.
LBDA looks forward to bringing you the full results as soon as they are made public by the study team.