This week Axovant Sciences released preliminary results for one of its LBD clinical trials of an experimental medication, nelotanserin.
The first eleven people with LBD have completed the Phase 2 study of nelotanserin for the treatment of visual hallucinations in either dementia with Lewy bodies (DLB) or Parkinson’s disease dementia (PDD). An interim analysis suggested a beneficial treatment of LBD motor symptoms, called parkinsonism, one of the primary endpoints of the study. No significant benefit was found for visual hallucinations, a secondary endpoint. The full study is expected to be completed in mid-2017 and the results presented by the end of the year.
This was a double-blind, placebo-controlled, cross-over study, which means neither the patient nor the physician knew who was receiving the study medication or a placebo (a pill with no active ingredients). All patients received either the placebo and were changed (“crossed over”) to the study medication, or vice versa, at some point during their participation There were no reported drug-related serious adverse effects, and no adverse effects that led to discontinuation of the study medication.
Expanded patient recruitment for a Phase 3 clinical trial is also being planned for later this year.