Non-Interventional Study With Aricept® Evess

Completed

• Conditions: Vascular Dementia; Alzheimer's Disease
• Interventions: Drug: Aricept® Evess

• Registration Number: NCT00889603
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2009-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-01-26
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-04
• Last Update Submitted: 2011-03-04
• Results First Posted: 2011-03-31
• Last Update Posted: 2011-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Aricept® Evess	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)	Baseline and Week 24	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in MMSE Total	Baseline, Week 8, 16, and 24	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.
Change From Baseline in Functional Activity Questionnaire (FAQ)	Baseline and Week 24	Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8	Week 8	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16	Week 16	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24	Week 24	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF	Week 24	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Number of Participants in Each Patient Domain of Benefit	Week 24	Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no').

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇷🇴 Iasi, Romania