To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus\* and SIB\*\* as the primary efficacy measures. Safety of E2020 will also be evaluated. (\*for overall evalution of clinical symtoms) (\*\*for cognitive function test)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Primary Outcomes: Efficacy:
CIBIC plus*, SIB**
(*for overall evalution of clinical symtoms)
(**for cognitive function test)
Safety:
Adverse event, adverse drug reaction, vital sign, clinical laboratory parameter, electrocardiogram
Efficacy
Behave-AD, ADCS-ADL-sev
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Unnamed facility
Chita, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Toyohashi, Aichi-ken, Japan
Unnamed facility
Akita, Akita, Japan
Unnamed facility
Akita, Akita, Japan
Unnamed facility
Daisen, Akita, Japan
Unnamed facility
Kashiwa, Chiba, Japan
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
...and 55 more locations