Non-Interventional Study With Aricept® Evess

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-03-31

Brief Summary

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The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.

Detailed Description

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Conditions

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Alzheimer's Disease Vascular Dementia

Keywords

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Aricept® Evess non-interventional study Alzheimer's Disease Vascular Dementia efficacy tolerability safety.

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Aricept® Evess

Intervention Type DRUG

5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets.

Treatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing).

Interventions

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Aricept® Evess

5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets.

Treatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients (male / female), older than 50 years.
* Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.
* MMSE score between 12 - 24.

Exclusion Criteria

* Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.
* Patients with severe impaired hepatic function.
* Patients with pre-existing gastrointestinal ulcer disease.
* Patients with the history of bronchial asthma or chronic obstructive lung disease.
* Patients with the history of serious atrioventricular conduction disturbances.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

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A2501065

Identifier Type: -

Identifier Source: org_study_id

Non-Interventional Study With Aricept® Evess

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Aricept® Evess

Interventions

Aricept® Evess

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Countries

Related Links

Other Identifiers

A2501065