With all the recent news about failed clinical trials for disease-modifying treatments for Alzheimer’s disease, a little encouraging news is timely. ACADIA Pharmaceuticals announced an early end to one of their studies because an interim analysis indicated the trial had met its primary endpoints.
In a recent press release, ACADIA revealed the HARMONY study of pimavanserin in dementia-related psychosis achieved “robust statistical superiority” over placebo in time to the relapse of psychosis. An independent monitory committee reviewed data from the interim analysis made the recommendation to halt the study early. The clinical trial was not specific to any one type of dementia. Participants with a variety of dementia sub-types were enrolled, specifically Alzheimer’s disease, Lewy body dementias, frontotemporal dementias and vascular dementia.
Medication sensitivities are common in people with dementia with Lewy bodies, one form of LBD. There have not yet been any clinical trials of pimavanserin specifically in this this population. Further study in an LBD cohort will be important to understand if the drug improves specific symptoms of LBD and whether there are any medication sensitivities for this dementia sub-type.
ACADIA will be meeting with the FDA in their pursuit of a second indication for dementia-related psychosis. Pimavanserin is FDA-approved for the treatment of psychosis in Parkinson’s disease.