Moline 2021

Current Status of Trial
Completed
Study Aim
Treatment Dementia
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Lemborexant // Placebo
Dosage and Duration
Patients were randomized to placebo or one of four lemborexant treatment arms (2.5 mg, 5 mg, 10 mg or 15 mg) once nightly at bedtime for 4 weeks.
Absolute Number of Participants
62
Health Status/Diagnosis
Alzheimer Disease (AD)
Main Diagnostic Criteria
Mini-Mental State Exam (MMSE) score 10 to 26
Co-morbid Health Condition/Other Participant Characteristics
60 to 90 years of age
Country or Countries of Recruitment
United States (USA) // Japan // United Kingdom (UK)
Primary outcomes
Circadian rhythm parameters // Nighttime sleep // Daytime wakefulness
Key Points
"Sixty-two subjects were randomized and provided data for circadian, daytime and nighttime parameters (placebo, n = 12; lemborexant 2.5 mg [LEM2.5], n = 12; lemborexant 5 mg [LEM5], n = 13, lemborexant 10 mg [LEM10], n = 13 and lemborexant 15 mg [LEM15], n = 12). Mean L5 showed a decrease from baseline to week 4 for LEM2.5, LEM5 and LEM15 that was significantly greater than with placebo (all p > 0.05), suggesting a reduction in restlessness. For RA, LS mean change from baseline to week 4 versus placebo indicated greater distinction between night and day with all dose levels of lemborexant, with significant improvements seen with LEM5 and LEM15 compared with placebo (both p > 0.05). The median percentage change from baseline to week 4 in MDSB during the daytime indicated a numerical decrease in duration for LEM5, LEM10 and LEM15, which was significantly different from placebo for LEM5 and LEM15 (p > 0.01 and p = 0.002, respectively). There were no serious treatment-emergent adverse events or worsening of cognitive function, as assessed by the MMSE and ADAS-Cog. Lemborexant was well tolerated. No subjects discontinued treatment." Moline 2021