Eisai and Purdue Pharma have begun the Phase II clinical study of lemborexant (E2006) to treat patients with mild-to-moderate Alzheimer's disease (AD) who suffer from irregular sleep-wake rhythm disorder (ISWRD).
ISWRD is a type of circadian rhythm disorder that causes a person to wake up at irregular intervals day and night.
The multi-centre, randomised Phase II study will test the efficacy and safety of lemborexant while examining 125 patients aged 65 to 90 with ISWRD and mild-to-moderate AD.
Patients will be randomised to be orally administered with lemborexant or placebo orally once-daily for four weeks.
The study will be primarily focused on determining baseline change in actigraphy-based sleep efficiency and wake efficiency during the last seven nights of treatment.
The changes will be determined using actigraphy, a non-invasive device worn on the wrist that is used to assess sleep-wake patterns continuously for many days.
Eisai neurology business group chief clinical officer and chief medical officer Lynn Kramer said: "Sleep-wake fragmentation and sleep complaints associated with dementia are serious problems both for patients and their caregivers.
"Through research and development on lemborexant, we are striving to potentially fulfil unmet medical needs for this type of sleep disorder."
The company has recently started a Phase III study of lemborexant in 950 patients with insomnia disorder.
Jointly developed by Eisai and Purdue Pharma, lemborexant is a dual orexin receptor antagonist that binds with the two subtypes of orexin receptors and is considered a major regulator of the sleep-wake system.