Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
1 other identifier
observational
894
1 country
106
Brief Summary
To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2016
CompletedJuly 24, 2023
January 1, 2017
4.9 years
December 1, 2010
July 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADAS-Jcog (test of cognitive function)
36 month (12 weeks and every 6 months)
Secondary Outcomes (1)
Adverse events/adverse drug reactions
36 months
Study Arms (1)
Donepezil Hydrochloride
Interventions
Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.
Eligibility Criteria
Patients with Alzheimer's Disease
You may qualify if:
- Patients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Patients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5.
You may not qualify if:
- Patients who used Aricept within 3 months prior to dosing.
- Patients registered this survey before.
- Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (106)
Unknown Facility
Anjo, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Daisen, Akita, Japan
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Hirosaki, Aomori, Japan
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Towada, Aomori, Japan
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Ichihara, Chiba, Japan
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Kashiwa, Chiba, Japan
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Sakura, Chiba, Japan
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Iyo, Ehime, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Tōon, Ehime, Japan
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Kitakyushu, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Ukiha, Fukuoka, Japan
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Iwaki, Fukushima, Japan
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Mizunami, Gifu, Japan
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Fujioka, Gunma, Japan
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Fukuyama, Hiroshima, Japan
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Kure, Hiroshima, Japan
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Miyoshi, Hiroshima, Japan
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Ōtake, Hiroshima, Japan
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Hakodate, Hokkaido, Japan
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Nayoro, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Otaru, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sunagawa, Hokkaido, Japan
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Aioi, Hyōgo, Japan
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Akashi, Hyōgo, Japan
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Amagasaki, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Moriya, Ibaraki, Japan
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Kanazawa, Ishikawa-ken, Japan
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Kita, Kagawa-ken, Japan
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Mitoyo, Kagawa-ken, Japan
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Ebina, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Nankoku, Kochi, Japan
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Uji, Kyoto, Japan
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Suzuka, Mie-ken, Japan
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Tsu, Mie-ken, Japan
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Yokkaichi, Mie-ken, Japan
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Sendai, Miyagi, Japan
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Kitamorokata, Miyazaki, Japan
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Iida, Nagano, Japan
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Matsumoto, Nagano, Japan
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Okaya, Nagano, Japan
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Sasebo, Nagasaki, Japan
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Ikoma, Nara, Japan
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Kashihara, Nara, Japan
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Saiki, Oita Prefecture, Japan
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Yufu, Oita Prefecture, Japan
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Kurashiki, Okayama-ken, Japan
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Izumisano, Osaka, Japan
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Kaizuka, Osaka, Japan
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Matsubara, Osaka, Japan
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Sakai, Osaka, Japan
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Sayama, Osaka, Japan
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Suita, Osaka, Japan
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Fukaya, Saitama, Japan
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Hannō, Saitama, Japan
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Iruma, Saitama, Japan
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Koshigaya, Saitama, Japan
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Sayama, Saitama, Japan
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Masuda, Shimane, Japan
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Hamamatsu, Shizuoka, Japan
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Adachi City, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Machida, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Minato, Tokyo, Japan
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Nakano City, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Taitō City, Tokyo, Japan
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Toshima City, Tokyo, Japan
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Kurayoshi, Tottori, Japan
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Nanto, Toyama, Japan
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Kinokawa, Wakayama, Japan
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Tendō, Yamagata, Japan
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Hagi, Yamaguchi, Japan
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Shūnan, Yamaguchi, Japan
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Ube, Yamaguchi, Japan
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Akita, Japan
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Chiba, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kochi, Japan
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Kyoto, Japan
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Nara, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
Unknown Facility
Ōita, Japan
Unknown Facility
Shizuoka, Japan
Unknown Facility
Yamanashi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shoya Yamakawa
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 2, 2010
Study Start
December 1, 2010
Primary Completion
October 14, 2015
Study Completion
February 18, 2016
Last Updated
July 24, 2023
Record last verified: 2017-01