CompletedNCT01129596Updated Nov 5, 2018

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 in Alzheimer's Disease, sponsored by Eisai Co., Ltd.. Completed at 722 sites in Japan. Per ClinicalTrials.gov, last updated 2018-11-05.

Sponsored by Eisai Co., Ltd. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 10,238
Sex: All

Study 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.

Conditions studied

Alzheimer's Disease

Browse trials for

Alzheimer Disease 3,675

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 10,238 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

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Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: 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

Exclusion criteria:

Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 10,238 participants (actual)
Patient registry: No

Groups and cohorts

1
Drug: donepezil hydrochloride

Interventions

Drugdonepezil hydrochloride
This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.

What researchers measure

Primary outcomes

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)

Study locations

722 sites

Aisai, Aichi, Japan
Chita, Aichi, Japan
Gamagori, Aichi, Japan
Handa, Aichi, Japan
Ichinomiya, Aichi, Japan
Inazawa, Aichi, Japan
Inuyama, Aichi, Japan
Kariya, Aichi, Japan
Kasugai, Aichi, Japan
Komaki, Aichi, Japan
Konan, Aichi, Japan
Nagoya, Aichi, Japan
Nishio, Aichi, Japan
Nisshin, Aichi, Japan
Obu, Aichi, Japan
Okazaki, Aichi, Japan
Owariasahi, Aichi, Japan
Seto, Aichi, Japan
Shinshiro, Aichi, Japan
Tahara, Aichi, Japan
Tokai, Aichi, Japan
Tokoname, Aichi, Japan
Toyoake, Aichi, Japan
Toyohashi, Aichi, Japan
Toyokawa, Aichi, Japan
Toyota, Aichi, Japan
Yatomi, Aichi, Japan
Daisen, Akita, Japan
Katagami, Akita, Japan
Odate, Akita, Japan
Oga, Akita, Japan
Semboku, Akita, Japan
Yokote, Akita, Japan
Yurihonjo, Akita, Japan
Yuzawa, Akita, Japan
Goshogawara, Aomori, Japan
Hachinohe, Aomori, Japan
Hirosaki, Aomori, Japan
Kamikita, Aomori, Japan
Kitatsugaru, Aomori, Japan
Mutsu, Aomori, Japan
Sannohe, Aomori, Japan
Towada, Aomori, Japan
Abiko, Chiba, Japan
Asahi, Chiba, Japan
Choshi, Chiba, Japan
Funabashi, Chiba, Japan
Ichihara, Chiba, Japan
Ichikawa, Chiba, Japan
Inzai, Chiba, Japan
Isumi, Chiba, Japan
Kashiwa, Chiba, Japan
Katori, Chiba, Japan
Kimitsu, Chiba, Japan
Kisarazu, Chiba, Japan
Matsudo, Chiba, Japan
Mobara, Chiba, Japan
Nagareyama, Chiba, Japan
Narita, Chiba, Japan
Sakura, Chiba, Japan
Sambu, Chiba, Japan
Sammu, Chiba, Japan
Tateyama, Chiba, Japan
Togane, Chiba, Japan
Yachimata, Chiba, Japan
Yachiyo, Chiba, Japan
Yotsukaido, Chiba, Japan
Imabari, Ehime, Japan
Iyo, Ehime, Japan
Kamiukena, Ehime, Japan
Matsuyama, Ehime, Japan
Minamiuwa, Ehime, Japan
Niihama, Ehime, Japan
Ozu, Ehime, Japan
Saijo, Ehime, Japan
Seiyo, Ehime, Japan
Shikokuchuo, Ehime, Japan
Toon, Ehime, Japan
Uwajima, Ehime, Japan
Yawatahama, Ehime, Japan
Echizen, Fukui, Japan
Katsuyama, Fukui, Japan
Mikatakaminaka, Fukui, Japan
Obama, Fukui, Japan
Sabae, Fukui, Japan
Sakai, Fukui, Japan
Tsuruga, Fukui, Japan
Asakura, Fukuoka, Japan
Chikugo, Fukuoka, Japan
Chikushino, Fukuoka, Japan
Chikushi, Fukuoka, Japan
Fukutsu, Fukuoka, Japan
Iizuka, Fukuoka, Japan
Itoshima, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kasuya, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Miyako, Fukuoka, Japan
Miyama, Fukuoka, Japan

Showing the first 100 of 722 sites.

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01129596
Lead sponsor: Eisai Co., Ltd.
Responsible party: Sponsor
First posted: May 24, 2010
Start date: Jun 10, 2010
Primary completion: Sep 25, 2015
Completion: Jun 23, 2016
Last update: Nov 5, 2018

Study contacts

Kenta Sumitomo

study director · Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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