N/A
N=370
Non-Interventional Study With Aricept® Evess
Alzheimer's Disease · Vascular Dementia
Bottom Line
View on ClinicalTrials.gov: NCT00889603 ↗Enrolled (actual)
370
Serious AEs
3.2%
Results posted
Mar 2011
Primary outcome: Primary: Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) — 1.92 Scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Aricept® Evess (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) |
1.92 | — |
| SECONDARY Change From Baseline in MMSE Total |
0.92; 1.56; 1.97 | — |
| SECONDARY Change From Baseline in Functional Activity Questionnaire (FAQ) |
— | — |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 |
5; 68; 194; 74; 8; 2 | — |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16 |
21; 119; 116; 66; 17; 2 | — |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 |
33; 129; 87; 62; 16; 2 | — |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF |
34; 133; 95; 70; 17; 2 | — |
| SECONDARY Number of Participants in Each Patient Domain of Benefit |
202; 215; 193 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00889603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.