Non-Interventional Study With Aricept® Evess

Pfizer370 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

370

Conditions

Alzheimer's Disease Vascular Dementia

Interventions

Aricept® EvessDRUG

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

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (12)

Pfizer Investigational Site

Bacau, Jud. Bacau, Romania

Pfizer Investigational Site

Cluj-Napoca, Jud. Cluj, Romania

Pfizer Investigational Site

Cluj-Napoca, Jud. Cluj, Romania

Outcomes

Primary Outcomes

Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)

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.

Time frame: Baseline and Week 24

Secondary Outcomes

Change From Baseline in MMSE Total

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.

Time frame: Baseline, Week 8, 16, and 24

Change From Baseline in Functional Activity Questionnaire (FAQ)

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.

Time frame: Baseline and Week 24

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at 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.

Time frame: Week 8

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16

Data from ClinicalTrials.gov

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