Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

March 31, 2015

Conditions
Alzheimer's Type Dementia
Interventions
DRUG

E2020

"Subjects in the Group-10 mg:~Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg"

DRUG

E2020

"Subjects in the Group-23 mg:~Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg"

Trial Locations (54)

Unknown

Anjo

Ōbu

Toyoake

Chikushi

Kitakyushu

Fukuoka

Miyoshi

Ōtake

Amagasaki

Himeji

Morioka

Numakunai

Kida

Takamatsu

Kawasaki

Sagamihara

Yokohama

Yokosuka

Maizuru

Nagasaki

Sendai

Kitamorokata

Ina

Nagaoka

Kurashiki

Ibaraki

Ikeda

Sakai

Sennan

Takatsuki

Age

Iruma

Kasukabe

Tokorozawa

Fuji

Izunokuni

Anan

Bunkyo-ku

Kodaira

Koto

Ōta-ku

Setagaya City

Suginami

Akita

Chiba

Fukuoka

Hiroshima

Kagoshima

Kochi

Kyoto

Nara

Osaka

Saitama

Tokushima

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT01539031 - Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease | Biotech Hunter | Biotech Hunter