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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129596
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : February 27, 2017
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
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.

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: donepezil hydrochloride

Study Type : Observational
Actual Enrollment : 10238 participants
Observational Model: Cohort
Time Perspective: Prospective
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-
Actual Study Start Date : June 10, 2010
Primary Completion Date : September 25, 2015
Study Completion Date : April 1, 2016

Group/Cohort Intervention/treatment
1 Drug: donepezil hydrochloride
This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.

Primary Outcome Measures :
  1. The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation [ Time Frame: 48 months(12 weeks and every 6 months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital, Clinical. Japan

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129596

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Aisai, Aichi, Japan
Chita, Aichi, Japan
Gamagori, Aichi, Japan
Handa, Aichi, Japan
Ichinomiya, Aichi, Japan
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Kariya, Aichi, Japan
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Hanamaki, Iwate, Japan
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Kitakami, Iwate, Japan
Miyako, Iwate, Japan
Morioka, Iwate, Japan
Ninohe, Iwate, Japan
Oshu, Iwate, Japan
Tono, Iwate, Japan
Ayauta, Kagawa, Japan
Kanonji, Kagawa, Japan
Kita, Kagawa, Japan
Marugame, Kagawa, Japan
Mitoyo, Kagawa, Japan
Sakaide, Kagawa, Japan
Sanuki, Kagawa, Japan
Shozu, Kagawa, Japan
Takamatsu, Kagawa, Japan
Aira, Kagoshima, Japan
Amami, Kagoshima, Japan
Hioki, Kagoshima, Japan
Ibusuki, Kagoshima, Japan
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Soh, Kagoshima, Japan
So, Kagoshima, Japan
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Atsugi, Kanagawa, Japan
Chigasaki, Kanagawa, Japan
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Miura, Kanagawa, Japan
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Odawara, Kanagawa, Japan
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Yamato, Kanagawa, Japan
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Aki, Kochi, Japan
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Nagaoka, Kochi, Japan
Nankoku, Kochi, Japan
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Aso, Kumamoto, Japan
Hitoyoshi, Kumamoto, Japan
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Koshi, Kumamoto, Japan
Minamata, Kumamoto, Japan
Tamana, Kumamoto, Japan
Uki, Kumamoto, Japan
Yamaga, Kumamoto, Japan
Yatsushiro, Kumamoto, Japan
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Iga, Mie, Japan
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Kumano, Mie, Japan
Kuwana, Mie, Japan
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Tsu, Mie, Japan
Watarai, Mie, Japan
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Osaki, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shiogama, Miyagi, Japan
Toda, Miyagi, Japan
Tome, Miyagi, Japan
Higashimorokata, Miyazaki, Japan
Hyuga, Miyazaki, Japan
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Koyu, Miyazaki, Japan
Kushima, Miyazaki, Japan
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Nichinan, Miyazaki, Japan
Nishiusuki, Miyazaki, Japan
Nobeoka, Miyazaki, Japan
Saito, Miyazaki, Japan
Azumino, Nagano, Japan
Chikuma, Nagano, Japan
Chino, Nagano, Japan
Hanishina, Nagano, Japan
Higashichikuma, Nagano, Japan
Iida, Nagano, Japan
Ina, Nagano, Japan
Kamiminochi, Nagano, Japan
Kiso, Nagano, Japan
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Kitasaku, Nagano, Japan
Komagane, Nagano, Japan
Komoro, Nagano, Japan
Matsumoto, Nagano, Japan
Okaya, Nagano, Japan
Saku, Nagano, Japan
Shimoina, Nagano, Japan
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Suwa, Nagano, Japan
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Ueda, Nagano, Japan
Goto, Nagasaki, Japan
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Isahaya, Nagasaki, Japan
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Nishisonogi, Nagasaki, Japan
Omura, Nagasaki, Japan
Sasebo, Nagasaki, Japan
Shimabara, Nagasaki, Japan
Tsushima, Nagasaki, Japan
Unzen, Nagasaki, Japan
Gose, Nara, Japan
Ikoma, Nara, Japan
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Tenri, Nara, Japan
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Yoshino, Nara, Japan
Gosen, Niigata, Japan
Joetsu, Niigata, Japan
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Mitsuke, Niigata, Japan
Murakami, Niigata, Japan
Nagaoka, Niigata, Japan
Ojiya, Niigata, Japan
Sado, Niigata, Japan
Sanjo, Niigata, Japan
Shibata, Niigata, Japan
Uonuma, Niigata, Japan
Hita, Oita, Japan
Kunisaki, Oita, Japan
Kusu, Oita, Japan
Nakatsu, Oita, Japan
Saiki, Oita, Japan
Tsukumi, Oita, Japan
Usa, Oita, Japan
Usuki, Oita, Japan
Yufu, Oita, Japan
Akaiwa, Okayama, Japan
Asakuchi, Okayama, Japan
Bizen, Okayama, Japan
Kaga, Okayama, Japan
Kasaoka, Okayama, Japan
Kume, Okayama, Japan
Kurashiki, Okayama, Japan
Mimasaka, Okayama, Japan
Niimi, Okayama, Japan
Soja, Okayama, Japan
Takahashi, Okayama, Japan
Tamano, Okayama, Japan
Tomata, Okayama, Japan
Tsuyama, Okayama, Japan
Ginowan, Okinawa, Japan
Ishigaki, Okinawa, Japan
Itoman, Okinawa, Japan
Kunigami, Okinawa, Japan
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Naha, Okinawa, Japan
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Nanjo, Okinawa, Japan
Tomigusuku, Okinawa, Japan
Urasoe, Okinawa, Japan
Uruma, Okinawa, Japan
Daito, Osaka, Japan
Fujiidera, Osaka, Japan
Habikino, Osaka, Japan
Hannan, Osaka, Japan
Higashiosaka, Osaka, Japan
Hirakata, Osaka, Japan
Ibaraki, Osaka, Japan
Ikeda, Osaka, Japan
Izumiotsu, Osaka, Japan
Izumisano, Osaka, Japan
Izumi, Osaka, Japan
Kadoma, Osaka, Japan
Kaizuka, Osaka, Japan
Kashiwara, Osaka, Japan
Katano, Osaka, Japan
Kawachinagano, Osaka, Japan
Kishiwada, Osaka, Japan
Matsubara, Osaka, Japan
Mino, Osaka, Japan
Moriguchi, Osaka, Japan
Neyagawa, Osaka, Japan
Osakasayama, Osaka, Japan
Sakai, Osaka, Japan
Sennan, Osaka, Japan
Settsu, Osaka, Japan
Suita, Osaka, Japan
Takaishi, Osaka, Japan
Takatsuki, Osaka, Japan
Tondabayashi, Osaka, Japan
Toyonaka, Osaka, Japan
Toyono, Osaka, Japan
Yao, Osaka, Japan
Imari, Saga, Japan
Kanzaki, Saga, Japan
Karatsu, Saga, Japan
Kishima, Saga, Japan
Nishimatsuura, Saga, Japan
Ogi, Saga, Japan
Takeo, Saga, Japan
Taku, Saga, Japan
Tosu, Saga, Japan
Ureshino, Saga, Japan
Ageo, Saitama, Japan
Asaka, Saitama, Japan
Chichibu, Saitama, Japan
Fujimino, Saitama, Japan
Fujimi, Saitama, Japan
Fukaya, Saitama, Japan
Gyoda, Saitama, Japan
Hanno, Saitama, Japan
Hanyu, Saitama, Japan
Hasuda, Saitama, Japan
Hidaka, Saitama, Japan
Hiki, Saitama, Japan
Honjo, Saitama, Japan
Iruma, Saitama, Japan
Kasukabe, Saitama, Japan
Kawagoe, Saitama, Japan
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Kazo, Saitama, Japan
Kitaadachi, Saitama, Japan
Kitamoto, Saitama, Japan
Konosu, Saitama, Japan
Koshigaya, Saitama, Japan
Kuki, Saitama, Japan
Kumagaya, Saitama, Japan
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Niiza, Saitama, Japan
Sakado, Saitama, Japan
Sayama, Saitama, Japan
Soka, Saitama, Japan
Toda, Saitama, Japan
Tokorozawa, Saitama, Japan
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Wako, Saitama, Japan
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Hikone, Shiga, Japan
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Koka, Shiga, Japan
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Omihachiman, Shiga, Japan
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Ritto, Shiga, Japan
Takashima, Shiga, Japan
Hamada, Shimane, Japan
Izumo, Shimane, Japan
Kanoashi, Shimane, Japan
Matsue, Shimane, Japan
Nita, Shimane, Japan
Oda, Shimane, Japan
Unnan, Shimane, Japan
Yasugi, Shimane, Japan
Atami, Shizuoka, Japan
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Fuji, Shizuoka, Japan
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Iwata, Shizuoka, Japan
Izu, Shizuoka, Japan
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Kamo, Shizuoka, Japan
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Kosai, Shizuoka, Japan
Mishima, Shizuoka, Japan
Numazu, Shizuoka, Japan
Omaezaki, Shizuoka, Japan
Shimada, Shizuoka, Japan
Shimoda, Shizuoka, Japan
Susono, Shizuoka, Japan
Tagata, Shizuoka, Japan
Ashikaga, Tochigi, Japan
Haga, Tochigi, Japan
Kanuma, Tochigi, Japan
Kawachi, Tochigi, Japan
Moka, Tochigi, Japan
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Nasu, Tochigi, Japan
Nikko, Tochigi, Japan
Otawara, Tochigi, Japan
Oyama, Tochigi, Japan
Sano, Tochigi, Japan
Utsunomiya, Tochigi, Japan
Anan, Tokushima, Japan
Awa, Tokushima, Japan
Itano, Tokushima, Japan
Mima, Tokushima, Japan
Miyoshi, Tokushima, Japan
Myozai, Tokushima, Japan
Naka, Tokushima, Japan
Naruto, Tokushima, Japan
Yoshinogawa, Tokushima, Japan
Adachi, Tokyo, Japan
Akiruno, Tokyo, Japan
Akishima, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chofu, Tokyo, Japan
Chuo, Tokyo, Japan
Edogawa, Tokyo, Japan
Fuchu, Tokyo, Japan
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Hachioji, Tokyo, Japan
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Hino, Tokyo, Japan
Inagi, Tokyo, Japan
Itabashi, Tokyo, Japan
Katsushika, Tokyo, Japan
Kita, Tokyo, Japan
Kiyose, Tokyo, Japan
Kodaira, Tokyo, Japan
Koganei, Tokyo, Japan
Kokubunji, Tokyo, Japan
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Koto, Tokyo, Japan
Kunitachi, Tokyo, Japan
Machida, Tokyo, Japan
Meguro, Tokyo, Japan
Minato, Tokyo, Japan
Mitaka, Tokyo, Japan
Musashino, Tokyo, Japan
Nakano, Tokyo, Japan
Nerima, Tokyo, Japan
Nishitokyo, Tokyo, Japan
Ome, Tokyo, Japan
Ota, Tokyo, Japan
Setagaya, Tokyo, Japan
Shibuya, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
Suginami, Tokyo, Japan
Sumida, Tokyo, Japan
Tachikawa, Tokyo, Japan
Tama, Tokyo, Japan
Toshima, Tokyo, Japan
Hino, Tottori, Japan
Iwami, Tottori, Japan
Kurayoshi, Tottori, Japan
Saihaku, Tottori, Japan
Sakaiminato, Tottori, Japan
Yazu, Tottori, Japan
Yonago, Tottori, Japan
Himi, Toyama, Japan
Imizu, Toyama, Japan
Nakaniikawa, Toyama, Japan
Namerikawa, Toyama, Japan
Nanto, Toyama, Japan
Takaoka, Toyama, Japan
Uozu, Toyama, Japan
Arida, Wakayama, Japan
Gobo, Wakayama, Japan
Ito, Wakayama, Japan
Iwade, Wakayama, Japan
Kainan, Wakayama, Japan
Kinokawa, Wakayama, Japan
Nishimuro, Wakayama, Japan
Tanabe, Wakayama, Japan
Nanyo, Yamagata, Japan
Sakata, Yamagata, Japan
Tendo, Yamagata, Japan
Tsuruoka, Yamagata, Japan
Yonezawa, Yamagata, Japan
Hagi, Yamaguchi, Japan
Hikari, Yamaguchi, Japan
Hofu, Yamaguchi, Japan
Iwakuni, Yamaguchi, Japan
Nagato, Yamaguchi, Japan
SanyoOnoda, Yamaguchi, Japan
Shimonoseki, Yamaguchi, Japan
Shunan, Yamaguchi, Japan
Ube, Yamaguchi, Japan
Yanai, Yamaguchi, Japan
Chuo, Yamanashi, Japan
Fuefuki, Yamanashi, Japan
Fujiyoshida, Yamanashi, Japan
Hokuto, Yamanashi, Japan
Kai, Yamanashi, Japan
Kofu, Yamanashi, Japan
Minamitsuru, Yamanashi, Japan
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Niigata, Japan
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Okayama, Japan
Okinawa, Japan
Osaka, Japan
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Saitama, Japan
Shizuoka, Japan
Tochigi, Japan
Tokushima, Japan
Tottori, Japan
Toyama, Japan
Wakayama, Japan
Yamagata, Japan
Yamaguchi, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Kenta Sumitomo Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Responsible Party: Eisai Co., Ltd. Identifier: NCT01129596     History of Changes
Other Study ID Numbers: ART05T
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents