Nelotanserin may not be an effective approach for motor and vocal manifestations of REM sleep behavior disorder (RBD) in patients with Lewy body dementia (DLB) and Parkinson’s disease dementia (PDD). This is evident from the study results published in Sleep Medicine.
This multicenter phase 2 study included 26 patients with DLB and 8 patients with PDD (mean age 71.3 ± 6.36 years), all of whom had video-polysomnography (vPSG) -confirmed RBD. After a single-blind placebo run-in period, the patients entered a 4-week double-blind treatment period in which they received either 80 mg nelotanserin (n = 16) or placebo (n = 18) at random.
During the run-in phase and at the end of treatment, the study researchers performed a nightly vPSG. They analyzed videos of all REM sleep periods to identify RBD behavior including movements and vocalizations.
In the total population, there was no difference between nelotanserin and placebo compared to baseline in terms of the mean frequency of simple / serious 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 = 0.354). There was also no difference in patients with DLB (difference in LS mean, -0.60; 95% CI, -3.45 to 2.25; P = 0.665) and in patients with PDD (difference in LS mean, -1.85; 95% CI, -23.68 to 19.99; P = 0.751).
The study researchers observed a slight improvement in the mean frequency of simple / serious and complex RBD events per 10 minutes of REM sleep from baseline up to week 4 based on vPSG in the nelotanserin (mean change from baseline, -0.923) and placebo Group (mean) change from baseline, -0.251).
In the general population, the study researchers observed improvements in the frequency per 10 minutes of all movement (mean change, -4,324), the frequency per 10 minutes of simple / minor movement, and from baseline to end of treatment in the nelotanserin placebo group Sounds (mean change, -2.875), frequency per 10 minutes of simple / important movements and sounds (mean change, -0.817) and frequency per 10 minutes of complex movements and sounds (mean change, -0.106).
A limitation of this study included the lack of an electromyogram activity measurement during REM sleep. This quantification could provide further information to assess the response of the RBD treatment.
Ultimately, the study researchers concluded that the video analysis method used in this study “can be used as an objective measure of outcome in future studies on RBD treatment”.
Disclosure: This clinical study was supported by Axovant Sciences. For a full list of the authors’ information, see the original reference.
Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Högl B. Nelotanserin as symptomatic treatment for sleep disorders with rapid eye movements: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson’s dementia. Schlaf Med. Published online on February 25, 2021. doi: 10.1016 / j.sleep.2021.02.038