Non-Interventional Study With Aricept® Evess

Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia

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 Overview

• Status: Completed
• Conditions: Vascular Dementia; Alzheimer's Disease
• Intervention / Treatment: Drug: Aricept® Evess

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• Romania
  • Bucuresti, Romania, 041902
    • Pfizer Investigational Site
  • Bucuresti, Romania, 061301
    • Pfizer Investigational Site
  • Bucuresti, Romania
    • Pfizer Investigational Site
  • Iasi, Romania, 700282
    • Pfizer Investigational Site
  • Jud. Bacau
    • Bacau, Jud. Bacau, Romania, 600114
      • Pfizer Investigational Site
  • Jud. Cluj
    • Cluj-Napoca, Jud. Cluj, Romania, 400001
      • Pfizer Investigational Site
    • Cluj-Napoca, Jud. Cluj, Romania
      • Pfizer Investigational Site
  • Jud. Constanta
    • Constanta, Jud. Constanta, Romania
      • Pfizer Investigational Site
  • Jud. Dolj
    • Craiova, Jud. Dolj, Romania
      • Pfizer Investigational Site
  • Jud. Iasi
    • Iasi, Jud. Iasi, Romania, 700282
      • Pfizer Investigational Site
  • Jud. Prahova
    • Ploiesti, Jud. Prahova, Romania
      • Pfizer Investigational Site
  • Jud. Timis
    • Timisoara, Jud. Timis, Romania
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Week 8
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at 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.	Week 16
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at 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.	Week 24
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF	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.	Week 24
Number of Participants in Each Patient Domain of Benefit	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').	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Tolerability	Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor	Week 24
Number of Participants Receiving Other Medications	Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): March 31, 2011
• Last Update Submitted That Met QC Criteria: March 4, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: tolerability; Alzheimer's Disease; non-interventional study; efficacy; Vascular Dementia; safety.; Aricept® Evess
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Dementia, Vascular; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: A2501065