Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

NCT ID: NCT01251718

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

894 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-01

Study Completion Date

2016-02-18

Brief Summary

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To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Donepezil Hydrochloride

donepezil hydrochloride

Intervention Type DRUG

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.

Interventions

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donepezil hydrochloride

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shoya Yamakawa

Role: STUDY_DIRECTOR

Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Locations

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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

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Ōita, , Japan

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Shizuoka, , Japan

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Yamanashi, , Japan

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Countries

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Japan

Other Identifiers

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ART06T

Identifier Type: -

Identifier Source: org_study_id

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