Non-Interventional Study With Aricept® Evess

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00889603
First received: April 27, 2009
Last updated: March 4, 2011
Last verified: March 2011
  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
Alzheimer's Disease
Vascular Dementia
Drug: Aricept® Evess

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in MMSE Total [ Time Frame: Baseline, Week 8, 16, and 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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').


Enrollment: 370
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Romania
Pfizer Investigational Site
Bacau, Jud. Bacau, Romania, 600114
Pfizer Investigational Site
Cluj-Napoca, Jud. Cluj, Romania
Pfizer Investigational Site
Cluj-Napoca, Jud. Cluj, Romania, 400001
Pfizer Investigational Site
Constanta, Jud. Constanta, Romania
Pfizer Investigational Site
Craiova, Jud. Dolj, Romania
Pfizer Investigational Site
Iasi, Jud. Iasi, Romania, 700282
Pfizer Investigational Site
Ploiesti, Jud. Prahova, Romania
Pfizer Investigational Site
Timisoara, Jud. Timis, Romania
Pfizer Investigational Site
Bucuresti, Romania
Pfizer Investigational Site
Bucuresti, Romania, 061301
Pfizer Investigational Site
Bucuresti, Romania, 041902
Pfizer Investigational Site
Iasi, Romania, 700282
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00889603     History of Changes
Other Study ID Numbers: A2501065
Study First Received: April 27, 2009
Results First Received: January 26, 2011
Last Updated: March 4, 2011
Health Authority: Romania: National Ethics Committee and National Medicine Agency

Keywords provided by Pfizer:
Aricept® Evess
non-interventional study
Alzheimer's Disease
Vascular Dementia
efficacy
tolerability
safety.

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014