Clinical trial NCT00889603: Non-Interventional Study With Aricept® Evess
Official title: Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Vascular Dementia
Keywords: Aricept® Evess
non-interventional study
Alzheimer's Disease
Vascular Dementia
efficacy
tolerability
safety.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 370
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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 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.

Primary outcomes:
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in MMSE Total
timeFrame: Baseline, Week 8, 16, and 24
measure: Change From Baseline in Functional Activity Questionnaire (FAQ)
timeFrame: Baseline and Week 24
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
timeFrame: Week 8
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
timeFrame: Week 16
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
timeFrame: Week 24
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
timeFrame: Week 24
measure: Number of Participants in Each Patient Domain of Benefit
timeFrame: Week 24
Other outcomes:
measure: Number of Participants With Treatment Tolerability
timeFrame: Week 24
measure: Number of Participants Receiving Other Medications
timeFrame: Baseline and Week 24
Locations:
city: Bacau
country: Romania
facility: Pfizer Investigational Site
state: Jud. Bacau
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Jud. Cluj
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Jud. Cluj
city: Constanta
country: Romania
facility: Pfizer Investigational Site
state: Jud. Constanta
city: Craiova
country: Romania
facility: Pfizer Investigational Site
state: Jud. Dolj
city: Iasi
country: Romania
facility: Pfizer Investigational Site
state: Jud. Iasi
city: Ploiesti
country: Romania
facility: Pfizer Investigational Site
state: Jud. Prahova
city: Timisoara
country: Romania
facility: Pfizer Investigational Site
state: Jud. Timis
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: