At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 285 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Suvorexant 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects With Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Suvorexant and Placebo for Sleep Initiation and Maintenance Disorders and Alzheimer Disease. Completed, enrolled 285 participants.
Detailed Summary
This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that suvorexant is superior to placebo in improving insomnia as measured by change from baseline in polysomnography (PSG)-derived total sleep time (TST) at Week 4.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionSep 2018
TodayJul 2026
First PostedApr 25, 2016
Enrollment StartMay 23, 2016
Primary CompletionSep 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.2 years ago
Interventions
Suvorexantdrug
10 mg tablet (may be increased to 20 mg tablet)
Placebodrug
Placebo to suvorexant