ABOUT THIS STUDY
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- Outpatients (male / female), older than 50 years.
- Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.
- MMSE score between 12 - 24.
- 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.
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Descriptive Information | ||||
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Brief Title | Non-Interventional Study With Aricept® Evess | |||
Official Title | Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
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. | |||
Condition |
| |||
Intervention | 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). | |||
Study Groups/Cohorts | 1
Intervention: Drug: Aricept® Evess | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 370 | |||
Original Estimated Enrollment | 400 | |||
Actual Study Completion Date | March 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 50 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Romania | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00889603 | |||
Other Study ID Numbers | A2501065 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2011 |