Lewy Bodies Study for Those with Sleep Behavior Disorders
Official Title
A Phase 2, double-blind, randomized, placebo-controlled study of nelotanserin versus placebo in patients with dementia with Lewy bodies (DLB) experiencing REM sleep behaviors (RBD)
Purpose
The purpose of this study is to evaluate the safety of the study drug called nelotanserin and to assess the effects of nelotanserin in those experiencing frequent REM sleep behavior disorders due to dementia with Lewy bodies. Nelotanserin (study drug) is an investigational product, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) or the government health agencies of any other countries.
Could this study be right for you?
- Age: 50-85
- Diagnosis: probable dementia with Lewy bodies or Parkinson's disease dementia
- AND diagnosis of REM sleep behavior disorder (RBD) with frequent RBD episodes
- Must have a study partner willing to serve as a collateral informant for study assessments
- MMSE Score: greater than or equal to 18 (Mini Mental State Examination score to be explained by the coordinator)