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Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01129596
First received: May 21, 2010
Last updated: June 11, 2014
Last verified: June 2014

May 21, 2010
June 11, 2014
June 2010
September 2015   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Test of cognitive function [ Time Frame: 48 months(12 weeks and every 6 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01129596 on ClinicalTrials.gov Archive Site
Not Provided
Adverse events / adverse drug reactions [ Time Frame: 0 to 48 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Hospital, Clinical. Japan

Alzheimer's Disease
Drug: donepezil hydrochloride
This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.
1
Intervention: Drug: donepezil hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10000
December 2015
September 2015   (final data collection date for primary outcome measure)

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:

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01129596
ART05T
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Kenta Sumitomo Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Eisai Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP