0762 Baseline characteristics: Solriamfetol’s effect on cognitive Health in Apnea participants during a Randomized Placebo-controlled study (SHARP)

Abstract

Abstract Introduction Patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) may experience cognitive impairment. Solriamfetol (Sunosi®) is a dopamine/norepinephrine reuptake inhibitor approved in the US and EU to treat EDS associated with OSA. The objective of this study is to assess whether solriamfetol reduces cognitive impairment in patients with EDS associated with OSA. Methods This phase 4, randomized, double-blind, placebo-controlled, crossover trial (NCT04789174) is enrolling adults with OSA and associated EDS (Epworth Sleepiness Scale score >10) and impaired cognitive function defined by an age-adjusted scaled score ≤8 on the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Coding subtest and a score ≥9 on the British Columbia–Cognitive Complaints Inventory (BC-CCI). Participants are randomized (1:1) to 2 weeks of placebo or solriamfetol (75 mg/day for 3 days, then 150 mg/day) during treatment period 1. After a 1-week washout, participants crossover to receive 2 weeks of the opposite treatment during treatment period 2. Assessments at baseline and after each treatment period include Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding administered 2, 4, 6, and 8 hours post-dose and the BC-CCI. The primary endpoint is change from baseline after each treatment period in the average of 2- and 4-hour post-dose RBANS Coding scores. A secondary endpoint is change from baseline after each treatment period in BC-CCI score. Target enrollment range is 116‒164 participants, pending interim analysis. Enrollment is ongoing; baseline characteristics to date are reported. Results As of October 20th, 2021, 33 participants have been randomized across 20 study sites in North America and Europe. In the intent-to-treat population to date (n=33), mean±SD age is 53.0±10.4, mean±SD BMI is 31.6±4.5, 64% are male, 70% are White (Black or African American, 24%; Asian, 6%), and most (91%) are not Hispanic or Latino. The mean±SD WAIS-IV Coding subtest age-correct scaled score is 6.7±1.3 at baseline, which is below previously observed scores in healthy individuals. Conclusion This ongoing study is the first to examine solriamfetol’s impact on cognitive impairment in participants with OSA. Participants enrolled to date reflect the typical demographics of patients with OSA and demonstrate substantial cognitive impairment. Support (If Any) Jazz Pharmaceuticals