A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

PHASE2CompletedINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Dementia With Lewy Bodies (DLB)
Interventions
DRUG

3 mg Donepezil hydrochloride

"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."

DRUG

5 mg Donepezil hydrochloride

"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."

DRUG

10 mg Donepezil hydrochloride

"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."

DRUG

Placebo

"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."

Trial Locations (43)

Unknown

Nagoya

Ōbu

Toyokawa

Akita

Chiba

Fukui-shi

Fukuoka

Kurume

Omuta

Maebashi

Miyoshi

Ōtake

Himeji

Kobe

Tsukuba

Kahoku

Morioka

Yokohama

Kochi

Nankoku

Kōshi

Kumamoto

Jōyō

Kyoto

Sendai

Komoro

Kashihara

Jōetsu

Sanjō

Yufu

Osaka

Sakai

Suita

Saitama

Izumo

Shizuoka

Bunkyo-ku

Kodaira

Koto-ku

Ōta-ku

Setagaya-ku

Shinjuku-ku

Ube

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT00543855 - A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431) | Biotech Hunter | Biotech Hunter