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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Aisai, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Donepezil Hydrochloride

Drug

This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2016
First posted: May 24, 2010
Registry last updated: Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed