Non-Interventional Study With Aricept® Evess - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00889603

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease Vascular Dementia	Drug: Aricept® Evess	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia

Further study details as provided by Pfizer:

Primary Outcome Measures:

The incidence of adverse events (AEs) - all causalities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Number and evaluation of serious adverse events (SAE's) reported [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Number and evaluation of premature discontinuation due to AEs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The evaluation of treatment tolerability at the final visit [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of efficacy based on Mini Mental State Examination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assessment of efficacy based on the Clinical Global Impression (CGI-I/CGI-S) scales [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The percentage of patients completing the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The patient's most beneficial domain after treatment - cognition, functionality or behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The proportion of patients receiving other medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	May 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Drug: 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).

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The patients will be selected from those addressing psychiatrists on an outpatient bases, male / female, older than 50 years, being diagnosed with Alzheimer's Disease and Vascular Dementia, with MMSE score between 12 - 24.

Criteria

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 clorhydrate, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889603

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2501065
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00889603 History of Changes
Health Authority:	Romania: Ethics Committee; Romania: National Medicines Agency

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Nootropic Agents
Neurotransmitter Agents
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases
Intracranial Arterial Diseases

Cerebrovascular Disorders
Cognition Disorders
Cholinesterase Inhibitors
Intracranial Arteriosclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Dementia, Vascular
Dementia
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arteriosclerosis
Neurodegenerative Diseases
Brain Diseases
Cholinergic Agents
Intracranial Arterial Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Mental Disorders
Therapeutic Uses
Donepezil
Dementia, Vascular

Cardiovascular Diseases
Dementia
Arterial Occlusive Diseases
Nootropic Agents
Nervous System Diseases
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009