Nelotanserin may not be an effective approach for motor and vocal manifestations of rapid eye movement (REM) sleep behavior disorder (RBD) in patients with dementia with Lewy bodies (DLB) and Parkinson disease dementia (PDD), according to study results published in Sleep Medicine.
This phase 2, multicenter study enrolled 26 patients with DLB and 8 patients with PDD (mean age, 71.3±6.36 years), all of whom had with RBD confirmed by video polysomnography (vPSG). Following a single-blind, placebo run-in period, patients entered a 4-week double-blind treatment period in which they were randomly assigned to receive either 80 mg nelotanserin (n=16) or placebo (n=18).
During the run-in phase and at the end of the treatment, the study researchers performed whole-night vPSG. They analyzed videos of all REM sleep periods to identify RBD behaviors, including movements and vocalizations.
In the overall population, there was no difference between nelotanserin and placebo compared with baseline in terms of the average frequency of simple/major and complex RBD events per 10 minutes of REM sleep (difference in least squares [LS] means, -1.20; 95% CI, -3.84 to 1.43; P =.354). There was also no difference in patients with DLB (difference in LS means, -0.60; 95% CI, -3.45 to 2.25; P =.665) and those with PDD (difference in LS mean changes, -1.85; 95% CI, -23.68 to 19.99; P =.751).
The study researchers observed a slight improvement from baseline to week 4 in the mean frequency of simple/major and complex RBD events per 10 minutes of REM sleep based on vPSG in the nelotanserin (mean change from baseline, -0.923) and placebo groups (mean change from baseline, -0.251).
In the overall population, the study researchers observed an improvement from baseline to end of treatment in the nelotanserin vs placebo group in the frequency per 10 minutes of all movements (mean change, -4.324), frequency per 10 minutes of simple/minor movements and vocalizations (mean change, -2.875), frequency per 10 minutes of simple/major movements and vocalizations (mean change, -0.817), and frequency per 10 minutes of complex movements and vocalizations (mean change, -0.106).
A limitation of this study included the absence of electromyogram activity measurement during REM sleep. This quantification could provide further information for assessment of RBD treatment response.
Ultimately, the study researchers concluded that the applied video analysis method used in this study “can be used as an objective outcome measure in future studies on RBD treatment.”
Disclosure: This clinical trial was supported by Axovant Sciences. Please see the original reference for a full list of authors’ disclosures.
Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Högl B. Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson’s disease dementia. Sleep Med. Published online February 25, 2021. doi:10.1016/j.sleep.2021.02.038