Clinical trial NCT01129596: Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 10238
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital, Clinical. Japan

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.


Eligibility 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.

Primary outcomes:
measure: The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation
timeFrame: 48 months(12 weeks and every 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Aisai
country: Japan
state: Aichi
city: Chita
country: Japan
state: Aichi
city: Gamagori
country: Japan
state: Aichi
city: Handa
country: Japan
state: Aichi
city: Ichinomiya
country: Japan
state: Aichi
city: Inazawa
country: Japan
state: Aichi
city: Inuyama
country: Japan
state: Aichi
city: Kariya
country: Japan
state: Aichi
city: Kasugai
country: Japan
state: Aichi
city: Komaki
country: Japan
state: Aichi
city: Konan
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nishio
country: Japan
state: Aichi
city: Nisshin
country: Japan
state: Aichi
city: Obu
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Owariasahi
country: Japan
state: Aichi
city: Seto
country: Japan
state: Aichi
city: Shinshiro
country: Japan
state: Aichi
city: Tahara
country: Japan
state: Aichi
city: Tokai
country: Japan
state: Aichi
city: Tokoname
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Toyokawa
country: Japan
state: Aichi
city: Toyota
country: Japan
state: Aichi
city: Yatomi
country: Japan
state: Aichi
city: Daisen
country: Japan
state: Akita
city: Katagami
country: Japan
state: Akita
city: Odate
country: Japan
state: Akita
city: Oga
country: Japan
state: Akita
city: Semboku
country: Japan
state: Akita
city: Yokote
country: Japan
state: Akita
city: Yurihonjo
country: Japan
state: Akita
city: Yuzawa
country: Japan
state: Akita
city: Goshogawara
country: Japan
state: Aomori
city: Hachinohe
country: Japan
state: Aomori
city: Hirosaki
country: Japan
state: Aomori
city: Kamikita
country: Japan
state: Aomori
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country: Japan
state: Aomori
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country: Japan
state: Aomori
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state: Aomori
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state: Aomori
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country: Japan
state: Chiba
city: Asahi
country: Japan
state: Chiba
city: Choshi
country: Japan
state: Chiba
city: Funabashi
country: Japan
state: Chiba
city: Ichihara
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Inzai
country: Japan
state: Chiba
city: Isumi
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Katori
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state: Chiba
city: Kimitsu
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state: Chiba
city: Kisarazu
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state: Chiba
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state: Chiba
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state: Chiba
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city: Tagawa
country: Japan
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city: Ukiha
country: Japan
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city: Yanagawa
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city: Aizuwakamatsu
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country: Japan
state: Fukushima
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country: Japan
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city: Higashishirakawa
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state: Fukushima
city: Ishikawa
country: Japan
state: Fukushima
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country: Japan
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city: Kitakata
country: Japan
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city: Date
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state: Niigata
city: Sanjo
country: Japan
state: Niigata
city: Shibata
country: Japan
state: Niigata
city: Uonuma
country: Japan
state: Niigata
city: Hita
country: Japan
state: Oita
city: Kunisaki
country: Japan
state: Oita
city: Kusu
country: Japan
state: Oita
city: Nakatsu
country: Japan
state: Oita
city: Saiki
country: Japan
state: Oita
city: Tsukumi
country: Japan
state: Oita
city: Usa
country: Japan
state: Oita
city: Usuki
country: Japan
state: Oita
city: Yufu
country: Japan
state: Oita
city: Akaiwa
country: Japan
state: Okayama
city: Asakuchi
country: Japan
state: Okayama
city: Bizen
country: Japan
state: Okayama
city: Kaga
country: Japan
state: Okayama
city: Kasaoka
country: Japan
state: Okayama
city: Kume
country: Japan
state: Okayama
city: Kurashiki
country: Japan
state: Okayama
city: Mimasaka
country: Japan
state: Okayama
city: Niimi
country: Japan
state: Okayama
city: Soja
country: Japan
state: Okayama
city: Takahashi
country: Japan
state: Okayama
city: Tamano
country: Japan
state: Okayama
city: Tomata
country: Japan
state: Okayama
city: Tsuyama
country: Japan
state: Okayama
city: Ginowan
country: Japan
state: Okinawa
city: Ishigaki
country: Japan
state: Okinawa
city: Itoman
country: Japan
state: Okinawa
city: Kunigami
country: Japan
state: Okinawa
city: Miyakojima
country: Japan
state: Okinawa
city: Naha
country: Japan
state: Okinawa
city: Nakagami
country: Japan
state: Okinawa
city: Nanjo
country: Japan
state: Okinawa
city: Tomigusuku
country: Japan
state: Okinawa
city: Urasoe
country: Japan
state: Okinawa
city: Uruma
country: Japan
state: Okinawa
city: Daito
country: Japan
state: Osaka
city: Fujiidera
country: Japan
state: Osaka
city: Habikino
country: Japan
state: Osaka
city: Hannan
country: Japan
state: Osaka
city: Higashiosaka
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Ibaraki
country: Japan
state: Osaka
city: Ikeda
country: Japan
state: Osaka
city: Izumiotsu
country: Japan
state: Osaka
city: Izumisano
country: Japan
state: Osaka
city: Izumi
country: Japan
state: Osaka
city: Kadoma
country: Japan
state: Osaka
city: Kaizuka
country: Japan
state: Osaka
city: Kashiwara
country: Japan
state: Osaka
city: Katano
country: Japan
state: Osaka
city: Kawachinagano
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Matsubara
country: Japan
state: Osaka
city: Mino
country: Japan
state: Osaka
city: Moriguchi
country: Japan
state: Osaka
city: Neyagawa
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Sakai
country: Japan
state: Osaka
city: Sennan
country: Japan
state: Osaka
city: Settsu
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Takaishi
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Tondabayashi
country: Japan
state: Osaka
city: Toyonaka
country: Japan
state: Osaka
city: Toyono
country: Japan
state: Osaka
city: Yao
country: Japan
state: Osaka
city: Imari
country: Japan
state: Saga
city: Kanzaki
country: Japan
state: Saga
city: Karatsu
country: Japan
state: Saga
city: Kishima
country: Japan
state: Saga
city: Nishimatsuura
country: Japan
state: Saga
city: Ogi
country: Japan
state: Saga
city: Takeo
country: Japan
state: Saga
city: Taku
country: Japan
state: Saga
city: Tosu
country: Japan
state: Saga
city: Ureshino
country: Japan
state: Saga
city: Ageo
country: Japan
state: Saitama
city: Asaka
country: Japan
state: Saitama
city: Chichibu
country: Japan
state: Saitama
city: Fujimino
country: Japan
state: Saitama
city: Fujimi
country: Japan
state: Saitama
city: Fukaya
country: Japan
state: Saitama
city: Gyoda
country: Japan
state: Saitama
city: Hanno
country: Japan
state: Saitama
city: Hanyu
country: Japan
state: Saitama
city: Hasuda
country: Japan
state: Saitama
city: Hidaka
country: Japan
state: Saitama
city: Hiki
country: Japan
state: Saitama
city: Honjo
country: Japan
state: Saitama
city: Iruma
country: Japan
state: Saitama
city: Kasukabe
country: Japan
state: Saitama
city: Kawagoe
country: Japan
state: Saitama
city: Kawaguchi
country: Japan
state: Saitama
city: Kazo
country: Japan
state: Saitama
city: Kitaadachi
country: Japan
state: Saitama
city: Kitamoto
country: Japan
state: Saitama
city: Konosu
country: Japan
state: Saitama
city: Koshigaya
country: Japan
state: Saitama
city: Kuki
country: Japan
state: Saitama
city: Kumagaya
country: Japan
state: Saitama
city: Minamisaitama
country: Japan
state: Saitama
city: Niiza
country: Japan
state: Saitama
city: Sakado
country: Japan
state: Saitama
city: Sayama
country: Japan
state: Saitama
city: Soka
country: Japan
state: Saitama
city: Toda
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Tsurugashima
country: Japan
state: Saitama
city: Wako
country: Japan
state: Saitama
city: Yoshikawa
country: Japan
state: Saitama
city: Higashiomi
country: Japan
state: Shiga
city: Hikone
country: Japan
state: Shiga
city: Inukami
country: Japan
state: Shiga
city: Koka
country: Japan
state: Shiga
city: Kusatsu
country: Japan
state: Shiga
city: Moriyama
country: Japan
state: Shiga
city: Nagahama
country: Japan
state: Shiga
city: Omihachiman
country: Japan
state: Shiga
city: Otsu
country: Japan
state: Shiga
city: Ritto
country: Japan
state: Shiga
city: Takashima
country: Japan
state: Shiga
city: Hamada
country: Japan
state: Shimane
city: Izumo
country: Japan
state: Shimane
city: Kanoashi
country: Japan
state: Shimane
city: Matsue
country: Japan
state: Shimane
city: Nita
country: Japan
state: Shimane
city: Oda
country: Japan
state: Shimane
city: Unnan
country: Japan
state: Shimane
city: Yasugi
country: Japan
state: Shimane
city: Atami
country: Japan
state: Shizuoka
city: Fujieda
country: Japan
state: Shizuoka
city: Fujinomiya
country: Japan
state: Shizuoka
city: Fuji
country: Japan
state: Shizuoka
city: Fukuroi
country: Japan
state: Shizuoka
city: Gotemba
country: Japan
state: Shizuoka
city: Haibara
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Ito
country: Japan
state: Shizuoka
city: Iwata
country: Japan
state: Shizuoka
city: Izu
country: Japan
state: Shizuoka
city: Kakegawa
country: Japan
state: Shizuoka
city: Kamo
country: Japan
state: Shizuoka
city: Kikugawa
country: Japan
state: Shizuoka
city: Kosai
country: Japan
state: Shizuoka
city: Mishima
country: Japan
state: Shizuoka
city: Numazu
country: Japan
state: Shizuoka
city: Omaezaki
country: Japan
state: Shizuoka
city: Shimada
country: Japan
state: Shizuoka
city: Shimoda
country: Japan
state: Shizuoka
city: Susono
country: Japan
state: Shizuoka
city: Tagata
country: Japan
state: Shizuoka
city: Ashikaga
country: Japan
state: Tochigi
city: Haga
country: Japan
state: Tochigi
city: Kanuma
country: Japan
state: Tochigi
city: Kawachi
country: Japan
state: Tochigi
city: Moka
country: Japan
state: Tochigi
city: Nasukarasuyama
country: Japan
state: Tochigi
city: Nasu
country: Japan
state: Tochigi
city: Nikko
country: Japan
state: Tochigi
city: Otawara
country: Japan
state: Tochigi
city: Oyama
country: Japan
state: Tochigi
city: Sano
country: Japan
state: Tochigi
city: Utsunomiya
country: Japan
state: Tochigi
city: Anan
country: Japan
state: Tokushima
city: Awa
country: Japan
state: Tokushima
city: Itano
country: Japan
state: Tokushima
city: Mima
country: Japan
state: Tokushima
city: Miyoshi
country: Japan
state: Tokushima
city: Myozai
country: Japan
state: Tokushima
city: Naka
country: Japan
state: Tokushima
city: Naruto
country: Japan
state: Tokushima
city: Yoshinogawa
country: Japan
state: Tokushima
city: Adachi
country: Japan
state: Tokyo
city: Akiruno
country: Japan
state: Tokyo
city: Akishima
country: Japan
state: Tokyo
city: Arakawa
country: Japan
state: Tokyo
city: Bunkyo
country: Japan
state: Tokyo
city: Chiyoda
country: Japan
state: Tokyo
city: Chofu
country: Japan
state: Tokyo
city: Chuo
country: Japan
state: Tokyo
city: Edogawa
country: Japan
state: Tokyo
city: Fuchu
country: Japan
state: Tokyo
city: Fussa
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Higashiyamato
country: Japan
state: Tokyo
city: Hino
country: Japan
state: Tokyo
city: Inagi
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Katsushika
country: Japan
state: Tokyo
city: Kita
country: Japan
state: Tokyo
city: Kiyose
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Koganei
country: Japan
state: Tokyo
city: Kokubunji
country: Japan
state: Tokyo
city: Komae
country: Japan
state: Tokyo
city: Koto
country: Japan
state: Tokyo
city: Kunitachi
country: Japan
state: Tokyo
city: Machida
country: Japan
state: Tokyo
city: Meguro
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Nakano
country: Japan
state: Tokyo
city: Nerima
country: Japan
state: Tokyo
city: Nishitokyo
country: Japan
state: Tokyo
city: Ome
country: Japan
state: Tokyo
city: Ota
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shibuya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Suginami
country: Japan
state: Tokyo
city: Sumida
country: Japan
state: Tokyo
city: Tachikawa
country: Japan
state: Tokyo
city: Tama
country: Japan
state: Tokyo
city: Toshima
country: Japan
state: Tokyo
city: Hino
country: Japan
state: Tottori
city: Iwami
country: Japan
state: Tottori
city: Kurayoshi
country: Japan
state: Tottori
city: Saihaku
country: Japan
state: Tottori
city: Sakaiminato
country: Japan
state: Tottori
city: Yazu
country: Japan
state: Tottori
city: Yonago
country: Japan
state: Tottori
city: Himi
country: Japan
state: Toyama
city: Imizu
country: Japan
state: Toyama
city: Nakaniikawa
country: Japan
state: Toyama
city: Namerikawa
country: Japan
state: Toyama
city: Nanto
country: Japan
state: Toyama
city: Takaoka
country: Japan
state: Toyama
city: Uozu
country: Japan
state: Toyama
city: Arida
country: Japan
state: Wakayama
city: Gobo
country: Japan
state: Wakayama
city: Ito
country: Japan
state: Wakayama
city: Iwade
country: Japan
state: Wakayama
city: Kainan
country: Japan
state: Wakayama
city: Kinokawa
country: Japan
state: Wakayama
city: Nishimuro
country: Japan
state: Wakayama
city: Tanabe
country: Japan
state: Wakayama
city: Nanyo
country: Japan
state: Yamagata
city: Sakata
country: Japan
state: Yamagata
city: Tendo
country: Japan
state: Yamagata
city: Tsuruoka
country: Japan
state: Yamagata
city: Yonezawa
country: Japan
state: Yamagata
city: Hagi
country: Japan
state: Yamaguchi
city: Hikari
country: Japan
state: Yamaguchi
city: Hofu
country: Japan
state: Yamaguchi
city: Iwakuni
country: Japan
state: Yamaguchi
city: Nagato
country: Japan
state: Yamaguchi
city: SanyoOnoda
country: Japan
state: Yamaguchi
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Shunan
country: Japan
state: Yamaguchi
city: Ube
country: Japan
state: Yamaguchi
city: Yanai
country: Japan
state: Yamaguchi
city: Chuo
country: Japan
state: Yamanashi
city: Fuefuki
country: Japan
state: Yamanashi
city: Fujiyoshida
country: Japan
state: Yamanashi
city: Hokuto
country: Japan
state: Yamanashi
city: Kai
country: Japan
state: Yamanashi
city: Kofu
country: Japan
state: Yamanashi
city: Minamitsuru
country: Japan
state: Yamanashi
city: Nirasaki
country: Japan
state: Yamanashi
city: Otsuki
country: Japan
state: Yamanashi
city: Tsuru
country: Japan
state: Yamanashi
city: Aichi
country: Japan
city: Akita
country: Japan
city: Aomori
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Ishikawa
country: Japan
city: Iwate
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Mie
country: Japan
city: Miyagi
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokushima
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
city: Yamagata
country: Japan
city: Yamaguchi
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Kenta Sumitomo
role: STUDY_DIRECTOR
References:
citation: Arai H, Hashimoto N, Sumitomo K, Takase T, Ishii M. Disease state changes and safety of long-term donepezil hydrochloride administration in patients with Alzheimer's disease: Japan-Great Outcome of Long-term trial with Donepezil (J-GOLD). Psychogeriatrics. 2018 Sep;18(5):402-411. doi: 10.1111/psyg.12340. Epub 2018 Jul 11.