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Observational Study Of Donepezil In Routine Clinical Practice

Last updated on January 19, 2020

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- DSM-IV criteria for the clinical diagnosis of mild to moderate Alzheimer's Disease
with or without other etiologies of dementia

- Mini Mental Status Examination score of 10-26

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Contraindication as stated in the Canadian label for donepezil

- Subjects treated with medication for dementia within 30 days prior to baseline

NCT00843115
Pfizer
Terminated
Observational Study Of Donepezil In Routine Clinical Practice

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Descriptive Information
Brief Title Observational Study Of Donepezil In Routine Clinical Practice
Official Title Ecological Perspective On The Efficacy And Tolerability Of Donepezil In A Routine Clinical Practice: A Patient Centered Observational Study
Brief Summary To characterize the comorbidities and medications of patients treated with donepezil in a routine clinical practice and to verify the therapeutic response of these patients.
Detailed Description This trial was terminated prematurely on December 31, 2007 due to difficulties in enrolling patients in the study. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Alzheimer's Disease with or without other etiologies of dementia
Condition Alzheimer's Disease
Intervention Other: donepezil
Routine clinical practice of prescribing donepezil as per the Canadian label. No drug was supplied as part of this study
Other Name: Aricept
Study Groups/Cohorts Observational
This study was non-interventional and simply followed for 3 months patients initiating a treatment with donepezil
Intervention: Other: donepezil
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 Terminated
Actual Enrollment
 (submitted: February 12, 2009)
370
Original Actual Enrollment Same as current
Actual Study Completion Date April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • DSM-IV criteria for the clinical diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia
  • Mini Mental Status Examination score of 10-26

Exclusion Criteria:

  • Contraindication as stated in the Canadian label for donepezil
  • Subjects treated with medication for dementia within 30 days prior to baseline
Sex/Gender
Sexes Eligible for Study: All
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00843115
Other Study ID Numbers NRA2500065
ECO STUDY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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