Download Phase 2 Trial Begins for Lemborexant for Irregular Sleep

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Phase 2 Trial Begins
for Lemborexant for
Irregular Sleep–Wake
Rhythm Disorder
U.S. Food and Drug Administration Grants Fast
Track Designation for New BACE Inhibitor for
Alzheimer’s Disease
© 2017 Shutterstock.com
Eisai, Inc., announced that it has received U.S. Food and Drug
Administration Fast Track designation for the development of E2609,
a beta-secretase cleaving enzyme
(BACE) inhibitor currently being
evaluated in Phase 3 clinical trials for
early Alzheimer’s disease (AD).
E2609 is an investigational nextgeneration oral candidate for the
treatment of AD that inhibits BACE,
a key enzyme in the production of
amyloid beta peptides. By inhibiting
BACE, E2609 may decrease the
formation of toxic amyloid beta peptide aggregates and amyloid plaques in the brain, thereby potentially
slowing disease progression. The first Phase 3 study for E2609 in the
clinical trial program called MISSIONAD began in October 2016 with
1,330 patients with biomarkers confirmed for early AD.
Eisai, Inc., and Purdue
Pharma announced the initiation
of a multi-center, randomized
Phase 2 clinical study (Study 202)
to evaluate Eisai’s oral dual orexin
receptor antagonist lemborexant
in patients with mild to moderate
Alzheimer’s disease (AD) who
experience irregular sleep–wake
rhythm disorder (ISWRD).
Study 202 will evaluate the
efficacy and safety of lemborexant
© 2017 Shutterstock.com
Source. “FDA Grants Fast Track Designation for Development of E2609, Eisai’s BACE
Inhibitor for Early Alzheimer’s Disease.” (2016, November 17). Retrieved December 1, 2016,
from http://prn.to/2h1YgHF.
in 125 patients ages 65 to 90 with
ISWRD and mild to moderate AD.
Patients will be randomized to
receive 2.5, 5, 10, or 15 mg of lemborexant or placebo orally once daily
for 4 weeks. Over the 4 weeks of
treatment with lemborexant compared to placebo, the primary endpoint will be the dose response of the
change from baseline in actigraphybased sleep and wake efficiency
during the last 7 nights of treatment.
These changes will be measured using
actigraphy, a non-invasive device
Journal of Gerontological Nursing • Vol. 43, No. 1, 2017
worn on the wrist that is used to
assess sleep–wake patterns continuously for many days.
Source. “Eisai Initiates Phase 2 Clinical
Trial to Evaluate Lemborexant in the Treatment of Irregular Sleep-Wake Rhythm Disorder (ISWRD) in Dementia Patients.” (2016,
October 31). Retrieved December 1, 2016, from
http://prn.to/2gHvZCR.
doi:10.3928/00989134-20161215-02
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