Safety&Efficacy of suvorexant for treatment of insomnia in AD subjects
Research type
Research Study
Full title
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
IRAS ID
204032
Contact name
Martin Allen
Contact email
Sponsor organisation
Merck Sharp & Dohme (UK) Limited
Eudract number
2015-003154-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 27 days
Research summary
Insomnia is common in Alzheimer Disease (AD), affecting up to 45% of individuals. Consequences span a wide range of potential morbidity leading to physical and mental impairments that can significantly affect capacity for daily self-care, leading to an increased need for and cost of healthcare and cause significant stress for family members and caregivers.
Options for effective pharmacological treatment of insomnia in AD are limited and currently available sleep agents have shown limited and inconsistent evidence of efficacy and safety in clinical trials, underlying the need of better improved therapies.
Orexin is a neurotransmitter (messenger of neurologic information between cells) playing a fundamental role in the regulation of the sleep-wake cycle by maintaining wakefulness. Suvorexant is a first-in-class Orexin Receptor Antagonist (ORA) that enables sleep to occur via selective antagonism of the orexin receptors OX1R and OX2R, which is approved in the treatment of insomnia in the United States and Japan. Via its novel ORA mechanism of action, suvorexant offers a potentially differentiating alternative treatment.
Approximately 260 male and female subjects aged 50 to 90 years with insomnia and AD will participate in this study for approximately 9weeks whilst the study will last for 14months.
Randomization will be done at a 1:1 ratio where subjects will receive either 10 mg of suvorexant or 10mg matching placebo. Subjects will take 1 tablet nightly throughout the duration of the 4 week treatment period. Dose may be increased to 20mg (at visit 5) upon investigator’s decision based on two criteria. The aim of this study is to evaluate the efficacy of suvorexant compared with placebo in improving insomnia and to evaluate its safety and tolerability for up to 4weeks of treatment.
The study is funded by Merck Sharp & Dohme Limited and will take place at 6 study centres in the UK.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0324
Date of REC Opinion
17 Oct 2016
REC opinion
Further Information Favourable Opinion