Non-Interventional Study With Aricept® Evess
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00889603
First received: April 27, 2009
Last updated: March 4, 2011
Last verified: March 2011
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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
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 May 16, 2013