Alzheimer's DiseaseNCT01129596
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
An observational study of Alzheimer's Disease, run by Eisai Co., Ltd. at 722 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- donepezil hydrochloride
- How many people
- 10,238 participants
- Where
- 722 sitesJapan
- Study dates
- 10 Jun 2010to 23 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital, Clinical. Japan
Who may be able to join
- 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.
Who cannot join
- Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.
Trial locations and contacts
722 sites in 1 country.
300 sites in 1 country
Japan300 sites
Study site
Abashiri, Hokkaido
Study site
Abiko, Chiba
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Adachi City, Tokyo
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Ageo, Saitama
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Aichi
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Aira, Kagoshima-ken
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Aisai, Aichi-ken
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Aizu-Wakamatsu, Fukushima
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Akaiwa, Okayama-ken
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Akashi, Hyōgo
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Aki, Hiroshima
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Aki, Kochi
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Akiruno, Tokyo
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Akishima, Tokyo
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Akita
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Akkeshi, Hokkaido
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Ako, Hyōgo
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Amagasaki, Hyōgo
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Amakusa, Kumamoto
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Amami, Kagoshima-ken
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Anan, Tokushima
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Aomori
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Arakawa City, Tokyo
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Arao, Kumamoto
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Arida, Wakayama
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Asago, Hyōgo
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Asahi, Chiba
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Asahikawa, Hokkaido
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Asaka, Saitama
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Asakuchi, Okayama-ken
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Asakura, Fukuoka
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Ashibetsu, Hokkaido
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Ashigarashimo, Kanagawa
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Ashikaga, Tochigi
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Ashiya, Hyōgo
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Aso, Kumamoto
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Atami, Shizuoka
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Atsugi, Kanagawa
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Awa, Tokushima
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Awaji, Hyōgo
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Ayauta, Kagawa-ken
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Azumino, Nagano
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Bandō, Ibaraki
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Bibai, Hokkaido
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Bizen, Okayama-ken
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Bunkyo, Tokyo
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Chiba
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Chichibu, Saitama
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Chigasaki, Kanagawa
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Chikugo, Fukuoka
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Chikuma, Nagano
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Chikusei, Ibaraki
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Chikushi, Fukuoka
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Chikushino-shi, Fukuoka
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Chino, Nagano
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Chita, Aichi-ken
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Chitose, Hokkaido
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Chiyoda City, Tokyo
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Chōfu, Tokyo
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Choshi, Chiba
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Chūō, Tokyo
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Chūō, Yamanashi
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Daisen, Akita
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Daitō, Osaka
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Date, Fukushima
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Date, Hokkaido
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Ebetsu, Hokkaido
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Ebina, Kanagawa
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Echizen, Fukui
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Edogawa City, Tokyo
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Ena, Gifu
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Eniwa, Hokkaido
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Fuchū, Hiroshima
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Fuchū, Tokyo
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Fuefuki, Yamanashi
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Fuji, Shizuoka
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Fujieda, Shizuoka
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Fujiidera, Osaka
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Fujimi, Saitama
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Fujimino, Saitama
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Fujinomiya, Shizuoka
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Fujioka, Gunma
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Fujisawa, Kanagawa
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Fujiyoshida, Yamanashi
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Fukagawa, Hokkaido
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Fukaya, Saitama
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Fukuchiyama, Kyoto
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Fukui
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Fukuoka
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Fukuroi, Shizuoka
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Fukushima
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Fukutsu, Fukuoka
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Fukuyama, Hiroshima
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Funabashi, Chiba
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Furano, Hokkaido
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Fussa, Tokyo
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Futaba, Fukushima
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Gamagōri, Aichi-ken
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Gifu
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Ginowan, Okinawa
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Gobō, Wakayama
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Gose, Nara
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Gosen, Niigata
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Goshogawara, Aomori
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Gotemba, Shizuoka
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Gotō, Nagasaki
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Gujō, Gifu
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Gyōda, Saitama
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Habikino, Osaka
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Hachinohe, Aomori
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Hachiōji, Tokyo
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Hagi, Yamaguchi
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Haibara, Shizuoka
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Hakodate, Hokkaido
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Hakusan, Ishikawa-ken
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Hamada, Shimane
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Hamamatsu, Shizuoka
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Hanamaki, Iwate
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Handa, Aichi-ken
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Hanishina, Nagano
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Hannan, Osaka
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Hannō, Saitama
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Hanyū, Saitama
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Hashima, Gifu
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Hasuda, Saitama
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Hidaka, Saitama
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Higashichikuma, Nagano
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Higashihiroshima, Hiroshima
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Higashiibaraki, Ibaraki
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Higashimorokata, Miyazaki
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Higashiōmi, Shiga
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Higashiosaka, Osaka
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Higashishirakawa, Fukushima
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Higashiyamato, Tokyo
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Hikari, Yamaguchi
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Hiki, Saitama
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Hikone, Shiga
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Himeji, Hyōgo
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Himi, Toyama
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Hino, Tokyo
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Hioki, Kagoshima-ken
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Hirakata, Osaka
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Hiratsuka, Kanagawa
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Hiroo, Hokkaido
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Hirosaki, Aomori
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Hiroshima
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Hita, Oita Prefecture
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Hitachi, Ibaraki
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Hitachi-Naka, Ibaraki
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Hitachiota, Ibaraki
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Hitoyoshi, Kumamoto
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Hōfu, Yamaguchi
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Hokuto, Hokkaido
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Hokuto, Yamanashi
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Honjō, Saitama
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Hyūga, Miyazaki
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Ibaraki, Osaka
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Ibusuki, Kagoshima-ken
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Ichihara, Chiba
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Ichikawa, Chiba
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Ichikikushikino, Kagoshima-ken
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Ichinomiya, Aichi-ken
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Ichinoseki, Iwate
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Iga, Mie-ken
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Iida, Nagano
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Iizuka, Fukuoka
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Ikeda, Osaka
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Ikoma, Nara
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Imabari, Ehime
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Imari, Saga-ken
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Imizu, Toyama
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Ina, Nagano
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Inagi, Tokyo
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Inashiki, Ibaraki
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Inazawa, Aichi-ken
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Inukami, Shiga
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Inuyama, Aichi-ken
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Inzai, Chiba
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Iruma, Saitama
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Isahaya, Nagasaki
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Ise, Mie-ken
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Isehara, Kanagawa
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Isesaki, Gunma
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Ishigaki, Okinawa
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Ishikari, Hokkaido
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Ishikawa, Fukushima
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Ishikawa
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Ishinomaki, Miyagi
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Ishioka, Ibaraki
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Isumi, Chiba
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Itami, Hyōgo
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Ito, Wakayama
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Itō, Shizuoka
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Itoman, Okinawa
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Itoshima, Fukuoka
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Iwade, Wakayama
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Iwai, Tottori
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Iwaki, Fukushima
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Iwakuni, Yamaguchi
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Iwamizawa, Hokkaido
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Iwanuma, Miyagi
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Iwata, Shizuoka
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Iyo, Ehime
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Izu, Shizuoka
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Izumi, Kagoshima-ken
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Izumi, Osaka
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Izumiōtsu, Osaka
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Izumisano, Osaka
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Izumo, Shimane
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Jōetsu, Niigata
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Jōsō, Ibaraki
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Jōyō, Kyoto
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Kadoma, Osaka
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Kaga, Okayama-ken
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Kagoshima
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Kahoku, Ishikawa-ken
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Kai, Yamanashi
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Kainan, Wakayama
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Kaizuka, Osaka
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Kakegawa, Shizuoka
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Kako, Hyōgo
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Kakogawa, Hyōgo
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Kamaishi, Iwate
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Kamakura, Kanagawa
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Kameda, Hokkaido
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Kameoka, Kyoto
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Kameyama, Mie-ken
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Kamiamakusa, Kumamoto
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Kamikawa, Hokkaido
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Kamikita, Aomori
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Kamimashiki, Kumamoto
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Kamiminochi, Nagano
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Kamisu, Ibaraki
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Kamiukena, Ehime
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Kamo, Shizuoka
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Kan’onjichō, Kagawa-ken
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Kanazawa, Ishikawa-ken
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Kanoashi, Shimane
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Kanoya, Kagoshima-ken
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Kanuma, Tochigi
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Kanzaki, Saga-ken
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Karatsu, Saga-ken
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Kariya, Aichi-ken
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Kasai, Hyōgo
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Kasama, Ibaraki
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Kasaoka, Okayama-ken
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Kashiba, Nara
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Kashihara, Nara
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Kashihara, Osaka
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Kashiwa, Chiba
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Kashiwazaki, Niigata
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Kasuga, Fukuoka
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Kasugai, Aichi-ken
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Kasukabe, Saitama
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Katagami, Akita
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Katano, Osaka
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Kato, Hokkaido
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Katō, Hyōgo
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Katori-shi, Chiba
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Katsushika-ku, Tokyo
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Katsuyama, Fukui
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Kawabe, Hyōgo
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Kawachi, Tochigi
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Kawachi-Nagano, Osaka
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Kawagoe, Saitama
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Kawaguchi, Saitama
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Kawakami, Hokkaido
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Kawanishi, Hyōgo
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Kawasaki, Kanagawa
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Kazo, Saitama
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Kesennuma, Miyagi
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Kikugawa, Shizuoka
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Kimitsu, Chiba
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Kinokawa, Wakayama
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Kirishima, Kagoshima-ken
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Kiryū, Gunma
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Kisarazu, Chiba
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Kishima, Saga-ken
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Kishiwada, Osaka
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Kiso, Nagano
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Kita, Kagawa-ken
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Kita-ku, Tokyo
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Kitaadachi, Saitama
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Kitaazumi, Nagano
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Kitagumma, Gunma
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Kitakami, Iwate
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Kitakata, Fukushima
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Kitakatsuragi, Nara
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Kitakyushu, Fukuoka
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Kitamatsuura, Nagasaki
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Kitami, Hokkaido
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Kitamoto, Saitama
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Kitasaku, Nagano
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Kitatsugaru, Aomori
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Kiyose, Tokyo
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Kizugawa, Kyoto
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Kobayashi, Miyazaki
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Kobe, Hyōgo
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Kochi
Study site
Kodaira, Tokyo
About this study
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.
- Conditions
- Alzheimer's Disease
- Being tested
- donepezil hydrochloride
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donepezil hydrochlorideDrug
This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: donepezil hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation
Measured: 48 months(12 weeks and every 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study start10 Jun 2010
- Primary completion25 Sep 2015
- Study completion23 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenta Sumitomo, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129596
- Sponsor's protocol ID
- ART05T
- Status last verified
- Jan 2017
- First submitted
- 21 May 2010
- Last updated
- 5 Nov 2018
- Results posted
- No
Publications
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.
PubMed 29993162
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT01129596
- Acronym / sponsor ID
- ART05T
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,238 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2010 (actual)
- Primary completion
- 25 Sep 2015 (actual)
- Study completion
- 23 Jun 2016 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: donepezil hydrochloride |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital, Clinical. Japan
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donepezil hydrochlorideThis is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified. | Drug | 1 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Background: PubMed 29993162Arai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenta Sumitomo study director
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
722 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Eisai Co., Ltd. at 722 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 722 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.