Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Condition(s) targeted: Alzheimer's Disease

Intervention: donepezil hydrochloride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Kenta Sumitomo, Study Director, Affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Overall contact:
Customer Information Services Department. CRC and QA Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug reactions, and patient background.

Official title: Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Test of cognitive function

Secondary outcome: Adverse events / adverse drug reactions

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patients diagnosed with Alzheimer's Disease by Diagnostic and Statistical Manual of

Mental Disorders (DSM-Ⅳ).

- Patients diagnosed with mild or moderate Alzheimer's Disease, applicable to FAST

score 4 or 5.

Exclusion criteria:

- Patients with history of hypersensitivity to component of Aricept or piperidine

derivative.

- Patients registered for this survey before.

Customer Information Services Department. CRC and QA Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

Sorachi-gun Hokkaido, Japan; Recruiting

Aichi-gun, Aichi, Japan; Recruiting

Chita-shi, Aichi, Japan; Recruiting

Gamagori-shi, Aichi, Japan; Recruiting

Handa-shi, Aichi, Japan; Recruiting

Hazu-gun, Aichi, Japan; Recruiting

Ichinomiya-shi, Aichi, Japan; Recruiting

Inazawa-shi, Aichi, Japan; Recruiting

Inuyama-shi, Aichi, Japan; Recruiting

Kasugai-shi, Aichi, Japan; Recruiting

Komaki-shi, Aichi, Japan; Recruiting

Konan-shi, Aichi, Japan; Recruiting

Nagoya-shi, Aichi, Japan; Recruiting

Obu-shi, Aichi, Japan; Recruiting

Owariasahi-shi, Aichi, Japan; Recruiting

Seto-shi, Aichi, Japan; Recruiting

Tahara-shi, Aichi, Japan; Recruiting

Tokai-shi, Aichi, Japan; Recruiting

Tokoname-shi, Aichi, Japan; Recruiting

Toyoake-shi, Aichi, Japan; Recruiting

Toyohashi-shi, Aichi, Japan; Recruiting

Toyota-shi, Aichi, Japan; Recruiting

Goshogawara-shi, Aomori, Japan; Recruiting

Isumi-gun, Chiba, Japan; Recruiting

Kisarazu-shi, Chiba, Japan; Recruiting

Mobara-shi, Chiba, Japan; Recruiting

Matsuyama-shi, Ehime, Japan; Recruiting

Fukui-shi, Fukui, Japan; Recruiting

Mikatakaminaka-gun, Fukui, Japan; Recruiting

Fukutsu-shi, Fukuoka, Japan; Recruiting

Kasuya-gun, Fukuoka, Japan; Recruiting

Kurume-shi, Fukuoka, Japan; Recruiting

Omua-shi, Fukuoka, Japan; Recruiting

Onojyo-shi, Fukuoka, Japan; Recruiting

Ukiha-shi, Fukuoka, Japan; Recruiting

Yanagawa-shi, Fukuoka, Japan; Recruiting

Futaba-gun, Fukushima, Japan; Recruiting

Iwaki-shi, Fukushima, Japan; Recruiting

Nihonmatsu-shi, Fukushima, Japan; Recruiting

Soma-shi, Fukushima, Japan; Recruiting

Gifu-shi, Gifu, Japan; Recruiting

Hashima-gun, Gifu, Japan; Recruiting

Mizuho-shi, Gifu, Japan; Recruiting

Toki-shi, Gifu, Japan; Recruiting

Yamagata-shi, Gifu, Japan; Recruiting

Kiryu-shi, Gumma, Japan; Recruiting

Hiroshima-shi, Hiroshima, Japan; Recruiting

Akkeshi-gun, Hokkaido, Japan; Recruiting

Asahikawa-shi, Hokkaido, Japan; Recruiting

Hakodate-shi, Hokkaido, Japan; Recruiting

Kato-gun, Hokkaido, Japan; Recruiting

Kawakami-gun, Hokkaido, Japan; Recruiting

Kushiro-shi, Hokkaido, Japan; Recruiting

Monbetsu-gun, Hokkaido, Japan; Recruiting

Obihiro-shi, Hokkaido, Japan; Recruiting

Sapporo-shi, Hokkaido, Japan; Recruiting

Mita-shi, Hyogo, Japan; Recruiting

Chikusei-shi, Ibaraki, Japan; Recruiting

Hitachinaka-shi, Ibaraki, Japan; Recruiting

Kamaishi-shi, Iwate, Japan; Recruiting

Mitoyo-shi, Kagawa, Japan; Recruiting

Sakaide-shi, Kagawa, Japan; Recruiting

Takamatsu-shi, Kagawa, Japan; Recruiting

Aira-shi, Kagoshima, Japan; Recruiting

Kagoshima-shi, Kagoshima, Japan; Recruiting

Kawasaki-shi, Kanagawa, Japan; Recruiting

Odawara-shi, Kanagawa, Japan; Recruiting

Yokohama-shi, Kanagawa, Japan; Recruiting

Kochi-shi, Kochi, Japan; Recruiting

Kumomoto-shi, Kumamoto, Japan; Recruiting

Kyoto-shi, Kyoto, Japan; Recruiting

Iga-shi, Mie, Japan; Recruiting

Kuwana-shi, Mie, Japan; Recruiting

Mie-gun, Mie, Japan; Recruiting

Suzuka-shi, Mie, Japan; Recruiting

Watarai-gun, Mie, Japan; Recruiting

Yokkaichi-shi, Mie, Japan; Recruiting

Kesennuma-shi, Miyagi, Japan; Recruiting

Nobeoka-shi, Miyazaki, Japan; Recruiting

Matsumoto-shi, Nagano, Japan; Recruiting

Niigata-shi, Niigata, Japan; Recruiting

Nakatsu-shi, Oita, Japan; Recruiting

Ikeda-shi, Osaka, Japan; Recruiting

Minoo-shi, Osaka, Japan; Recruiting

Osaka-shi, Osaka, Japan; Recruiting

Toyonaka-shi, Osaka, Japan; Recruiting

Saga-shi, Saga, Japan; Recruiting

Fukaya-shi, Saitama, Japan; Recruiting

Hasuda-shi, Saitama, Japan; Recruiting

Saitama-shi, Saitama, Japan; Recruiting

Sakado-shi, Saitama, Japan; Recruiting

Sayama-shiy, Saitama, Japan; Recruiting

Otsu-shi, Shiga, Japan; Recruiting

Fuji-shi, Shizuoka, Japan; Recruiting

Hamamatsu-shi, Shizuoka, Japan; Recruiting

Izu-shi, Shizuoka, Japan; Recruiting

Kosai-shi, Shizuoka, Japan; Recruiting

Mishima-shi, Shizuoka, Japan; Recruiting

Shimada-shi, Shizuoka, Japan; Recruiting

Shizuoka-shi, Shizuoka, Japan; Recruiting

Susono-shi, Shizuoka, Japan; Recruiting

Minamisaitama-gun, Sitama, Japan; Recruiting

Ashikaga-shi, Tochigi, Japan; Recruiting

Tochigi-shi, Tochigi, Japan; Recruiting

Adachi-ku, Tokyo, Japan; Recruiting

Edogawa-ku, Tokyo, Japan; Recruiting

Hachioji-shi, Tokyo, Japan; Recruiting

Hino-shi, Tokyo, Japan; Recruiting

Inagi-shi, Tokyo, Japan; Recruiting

Katsushika-ku, Tokyo, Japan; Recruiting

Koto-ku, Tokyo, Japan; Recruiting

Ota-ku, Tokyo, Japan; Recruiting

Setagaya-ku, Tokyo, Japan; Recruiting

Suginami-ku, Tokyo, Japan; Recruiting

Sumida-ku, Tokyo, Japan; Recruiting

Tachikawa-shi, Tokyo, Japan; Recruiting

Machida-shi, Tokyo9, Japan; Recruiting

Toyama-shi, Toyama, Japan; Recruiting

Uozu-shi, Toyama, Japan; Recruiting

Iwade-shi, Wakayama, Japan; Recruiting

Wakayama-shi, Wakayama, Japan; Recruiting

Iwakuni-shi, Yamaguchi, Japan; Recruiting

Ube-shi, Yamaguchi, Japan; Recruiting

Kofu-shi, Yamanashi, Japan; Recruiting

Starting date: June 2010
Last updated: June 30, 2010