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

NCT01129596 — Completed, 10238 participants, Eisai Co., Ltd.

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RegistryNCT01129596
StatusCompleted
Study typeObservational
Enrollment10238 (Actual)
SponsorEisai Co., Ltd. (Industry)
ConditionsAlzheimer's Disease
Interventionsdonepezil hydrochloride (Drug)
Datesstart 2010-06-10, primary completion 2015-09-25, completion 2016-06-23, first posted 2010-05-24, last updated 2018-11-05
Locations722 sites in Japan

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
1Drug: donepezil hydrochloride
  • donepezil hydrochloride (Drug): This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.

+Outcome measures

Primary outcomes

  • The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation [48 months(12 weeks and every 6 months)]

+Eligibility

Sex: All

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.

+Locations (722)

FacilityCityCountryStatus
Aisai, Aichi-kenJapan
Chita, Aichi-kenJapan
Gamagōri, Aichi-kenJapan
Handa, Aichi-kenJapan
Ichinomiya, Aichi-kenJapan
Inazawa, Aichi-kenJapan
Inuyama, Aichi-kenJapan
Kariya, Aichi-kenJapan
Kasugai, Aichi-kenJapan
Komaki, Aichi-kenJapan
Kōnan, Aichi-kenJapan
Nagoya, Aichi-kenJapan
Nishio, Aichi-kenJapan
Nisshin, Aichi-kenJapan
Okazaki, Aichi-kenJapan
Owariasahi, Aichi-kenJapan
Ōbu, Aichi-kenJapan
Seto, Aichi-kenJapan
Shinshiro, Aichi-kenJapan
Tahara, Aichi-kenJapan
Tokoname, Aichi-kenJapan
Toyoake, Aichi-kenJapan
Toyohashi, Aichi-kenJapan
Toyokawa, Aichi-kenJapan
Toyota, Aichi-kenJapan
Tōkai, Aichi-kenJapan
Yatomi, Aichi-kenJapan
Daisen, AkitaJapan
Katagami, AkitaJapan
Oga, AkitaJapan
Ōdate, AkitaJapan
Semboku, AkitaJapan
Yokote, AkitaJapan
Yurihonjō, AkitaJapan
Yuzawa, AkitaJapan
Goshogawara, AomoriJapan
Hachinohe, AomoriJapan
Hirosaki, AomoriJapan
Kamikita, AomoriJapan
Kitatsugaru, AomoriJapan
Mutsu, AomoriJapan
Sannohe, AomoriJapan
Towada, AomoriJapan
Abiko, ChibaJapan
Asahi, ChibaJapan
Choshi, ChibaJapan
Funabashi, ChibaJapan
Ichihara, ChibaJapan
Ichikawa, ChibaJapan
Inzai, ChibaJapan
Isumi, ChibaJapan
Kashiwa, ChibaJapan
Katori-shi, ChibaJapan
Kimitsu, ChibaJapan
Kisarazu, ChibaJapan
Matsudo, ChibaJapan
Mobara, ChibaJapan
Nagareyama, ChibaJapan
Narita, ChibaJapan
Sakura, ChibaJapan
Sambu, ChibaJapan
Sanmu, ChibaJapan
Tateyama, ChibaJapan
Tōgane, ChibaJapan
Yachimata, ChibaJapan
Yachiyo, ChibaJapan
Yotsukaidō, ChibaJapan
Imabari, EhimeJapan
Iyo, EhimeJapan
Kamiukena, EhimeJapan
Matsuyama, EhimeJapan
Minamiuwa, EhimeJapan
Niihama, EhimeJapan
Ōzu, EhimeJapan
Saijō, EhimeJapan
Seiyo, EhimeJapan
Shikokuchūō, EhimeJapan
Tōon, EhimeJapan
Uwajima, EhimeJapan
Yawatahama, EhimeJapan
Echizen, FukuiJapan
Katsuyama, FukuiJapan
Mikatakaminaka, FukuiJapan
Obama, FukuiJapan
Sabae, FukuiJapan
Sakai, FukuiJapan
Tsuruga, FukuiJapan
Asakura, FukuokaJapan
Chikugo, FukuokaJapan
Chikushi, FukuokaJapan
Chikushino-shi, FukuokaJapan
Fukutsu, FukuokaJapan
Iizuka, FukuokaJapan
Itoshima, FukuokaJapan
Kasuga, FukuokaJapan
Kitakyushu, FukuokaJapan
Koga, FukuokaJapan
Kurume, FukuokaJapan
Miyako, FukuokaJapan
Miyama, FukuokaJapan

622 more sites not listed.

+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. PMID 29993162

+Investigators

  • Kenta Sumitomo, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

My Notes