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

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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: donepezil hydrochloride

• Study Type: Observational
• Enrollment (Actual): 894

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Fukushima, Japan
  • Gifu, Japan
  • Hiroshima, Japan
  • Kagoshima, Japan
  • Kochi, Japan
  • Kyoto, Japan
  • Nara, Japan
  • Niigata, Japan
  • Oita, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Shizuoka, Japan
  • Yamanashi, Japan
  • Aichi
    • Anjo, Aichi, Japan
    • Nagoya, Aichi, Japan
  • Akita
    • Daisen, Akita, Japan
  • Aomori
    • Hirosaki, Aomori, Japan
    • Towada, Aomori, Japan
  • Chiba
    • Ichihara, Chiba, Japan
    • Kashiwa, Chiba, Japan
    • Sakura, Chiba, Japan
  • Ehime
    • Iyo, Ehime, Japan
    • Matsuyama, Ehime, Japan
    • Niihama, Ehime, Japan
    • Toon, Ehime, Japan
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
    • Omuta, Fukuoka, Japan
    • Ukiha, Fukuoka, Japan
  • Fukushima
    • Iwaki, Fukushima, Japan
  • Gifu
    • Mizunami, Gifu, Japan
  • Gumma
    • Fujioka, Gumma, Japan
  • Hiroshima
    • Fukuyama, Hiroshima, Japan
    • Kure, Hiroshima, Japan
    • Miyoshi, Hiroshima, Japan
    • Otake, Hiroshima, Japan
  • Hokkaido
    • Hakodate, Hokkaido, Japan
    • Nayoro, Hokkaido, Japan
    • Obihiro, Hokkaido, Japan
    • Otaru, Hokkaido, Japan
    • Sapporo, Hokkaido, Japan
    • Sunagawa, Hokkaido, Japan
  • Hyogo
    • Aioi, Hyogo, Japan
    • Akashi, Hyogo, Japan
    • Amagasaki, Hyogo, Japan
    • Himeji, Hyogo, Japan
    • Kobe, Hyogo, Japan
  • Ibaraki
    • Moriya, Ibaraki, Japan
  • Ishikawa
    • Kanazawa, Ishikawa, Japan
  • Kagawa
    • Kita, Kagawa, Japan
    • Mitoyo, Kagawa, Japan
  • Kanagawa
    • Ebina, Kanagawa, Japan
    • Kawasaki, Kanagawa, Japan
    • Yokohama, Kanagawa, Japan
    • Yokosuka, Kanagawa, Japan
  • Kochi
    • Nankoku, Kochi, Japan
  • Kyoto
    • Uji, Kyoto, Japan
  • Mie
    • Suzuka, Mie, Japan
    • Tsu, Mie, Japan
    • Yokkaichi, Mie, Japan
  • Miyagi
    • Sendai, Miyagi, Japan
  • Miyazaki
    • Kitamorokata, Miyazaki, Japan
  • Nagano
    • Iida, Nagano, Japan
    • Matsumoto, Nagano, Japan
    • Okaya, Nagano, Japan
  • Nagasaki
    • Sasebo, Nagasaki, Japan
  • Nara
    • Ikoma, Nara, Japan
    • Kashihara, Nara, Japan
  • Oita
    • Saiki, Oita, Japan
    • Yufu, Oita, Japan
  • Okayama
    • Kurashiki, Okayama, Japan
  • Osaka
    • Izumisano, Osaka, Japan
    • Kaizuka, Osaka, Japan
    • Matsubara, Osaka, Japan
    • Osakasayama, Osaka, Japan
    • Sakai, Osaka, Japan
    • Suita, Osaka, Japan
  • Saitama
    • Fukaya, Saitama, Japan
    • Hanno, Saitama, Japan
    • Iruma, Saitama, Japan
    • Koshigaya, Saitama, Japan
    • Sayama, Saitama, Japan
  • Shimane
    • Masuda, Shimane, Japan
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
  • Tokyo
    • Adachi, Tokyo, Japan
    • Bunkyo, Tokyo, Japan
    • Hachioji, Tokyo, Japan
    • Itabashi, Tokyo, Japan
    • Katsushika, Tokyo, Japan
    • Machida, Tokyo, Japan
    • Meguro, Tokyo, Japan
    • Minato, Tokyo, Japan
    • Nakano, Tokyo, Japan
    • Setagaya, Tokyo, Japan
    • Shinjuku, Tokyo, Japan
    • Taito, Tokyo, Japan
    • Toshima, Tokyo, Japan
  • Tottori
    • Kurayoshi, Tottori, Japan
  • Toyama
    • Nanto, Toyama, Japan
  • Wakayama
    • Kinokawa, Wakayama, Japan
  • Yamagata
    • Tendo, Yamagata, Japan
  • Yamaguchi
    • Hagi, Yamaguchi, Japan
    • Shunan, Yamaguchi, Japan
    • Ube, Yamaguchi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Alzheimer's Disease

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Donepezil Hydrochloride	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ADAS-Jcog (test of cognitive function)	36 month (12 weeks and every 6 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events/adverse drug reactions	36 months

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Shoya Yamakawa, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): October 14, 2015
• Study Completion (Actual): February 18, 2016

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimated): December 2, 2010

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Donepezil hydrochloride
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: ART06T