Clinical trial NCT01251718: Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
Official title: Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Donepezil hydrochloride
Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 894
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's Disease

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


Eligibility criteria: 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.

Primary outcomes:
measure: ADAS-Jcog (test of cognitive function)
timeFrame: 36 month (12 weeks and every 6 months)
Secondary outcomes:
measure: Adverse events/adverse drug reactions
timeFrame: 36 months
Other outcomes:
Locations:
city: Anjo
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Daisen
country: Japan
state: Akita
city: Hirosaki
country: Japan
state: Aomori
city: Towada
country: Japan
state: Aomori
city: Ichihara
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Sakura
country: Japan
state: Chiba
city: Iyo
country: Japan
state: Ehime
city: Matsuyama
country: Japan
state: Ehime
city: Niihama
country: Japan
state: Ehime
city: Toon
country: Japan
state: Ehime
city: Kitakyushu
country: Japan
state: Fukuoka
city: Omuta
country: Japan
state: Fukuoka
city: Ukiha
country: Japan
state: Fukuoka
city: Iwaki
country: Japan
state: Fukushima
city: Mizunami
country: Japan
state: Gifu
city: Fujioka
country: Japan
state: Gumma
city: Fukuyama
country: Japan
state: Hiroshima
city: Kure
country: Japan
state: Hiroshima
city: Miyoshi
country: Japan
state: Hiroshima
city: Otake
country: Japan
state: Hiroshima
city: Hakodate
country: Japan
state: Hokkaido
city: Nayoro
country: Japan
state: Hokkaido
city: Obihiro
country: Japan
state: Hokkaido
city: Otaru
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sunagawa
country: Japan
state: Hokkaido
city: Aioi
country: Japan
state: Hyogo
city: Akashi
country: Japan
state: Hyogo
city: Amagasaki
country: Japan
state: Hyogo
city: Himeji
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Moriya
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Kita
country: Japan
state: Kagawa
city: Mitoyo
country: Japan
state: Kagawa
city: Ebina
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Nankoku
country: Japan
state: Kochi
city: Uji
country: Japan
state: Kyoto
city: Suzuka
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Yokkaichi
country: Japan
state: Mie
city: Sendai
country: Japan
state: Miyagi
city: Kitamorokata
country: Japan
state: Miyazaki
city: Iida
country: Japan
state: Nagano
city: Matsumoto
country: Japan
state: Nagano
city: Okaya
country: Japan
state: Nagano
city: Sasebo
country: Japan
state: Nagasaki
city: Ikoma
country: Japan
state: Nara
city: Kashihara
country: Japan
state: Nara
city: Saiki
country: Japan
state: Oita
city: Yufu
country: Japan
state: Oita
city: Kurashiki
country: Japan
state: Okayama
city: Izumisano
country: Japan
state: Osaka
city: Kaizuka
country: Japan
state: Osaka
city: Matsubara
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Sakai
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Fukaya
country: Japan
state: Saitama
city: Hanno
country: Japan
state: Saitama
city: Iruma
country: Japan
state: Saitama
city: Koshigaya
country: Japan
state: Saitama
city: Sayama
country: Japan
state: Saitama
city: Masuda
country: Japan
state: Shimane
city: Hamamatsu
country: Japan
state: Shizuoka
city: Adachi
country: Japan
state: Tokyo
city: Bunkyo
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Katsushika
country: Japan
state: Tokyo
city: Machida
country: Japan
state: Tokyo
city: Meguro
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Nakano
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Taito
country: Japan
state: Tokyo
city: Toshima
country: Japan
state: Tokyo
city: Kurayoshi
country: Japan
state: Tottori
city: Nanto
country: Japan
state: Toyama
city: Kinokawa
country: Japan
state: Wakayama
city: Tendo
country: Japan
state: Yamagata
city: Hagi
country: Japan
state: Yamaguchi
city: Shunan
country: Japan
state: Yamaguchi
city: Ube
country: Japan
state: Yamaguchi
city: Akita
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kyoto
country: Japan
city: Nara
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
city: Yamanashi
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Shoya Yamakawa
role: STUDY_DIRECTOR
References: