The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation
10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.
Unnamed facility
Akita, Akita, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Mizunami, Gifu, Japan
Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
Time frame: Visit 2 [Day1] and Visit 3 [Day 15]
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
All subjects were identified as Extensive Metabolizer \[EM\] or Intermediate Metabolizer \[IM\] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i
Time frame: Visit 2 [Day1] and Visit 3 [Day 15]
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Unnamed facility
Yokosuka, Kanagawa, Japan
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Sanjō, Niigata, Japan
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Kurashiki, Okayama-ken, Japan
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Saitama, Saitama, Japan
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Fuji, Shizuoka, Japan
Unnamed facility
Hachiōji, Tokyo, Japan
...and 1 more locations