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Observational Study Of Donepezil In Routine Clinical Practice

This study has been terminated.
(See Detailed Description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00843115
First received: February 12, 2009
Last updated: July 10, 2009
Last verified: July 2009
History of Changes
Results First Received: April 8, 2009  
Study Type: Observational
Study Design: Observational Model: Ecologic or Community;   Time Perspective: Prospective
Condition: Alzheimer's Disease
Intervention: Other: donepezil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a non interventional study conducted at 62 sites in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had a diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia.

Reporting Groups
  Description
Donepezil As per physician prescription

Participant Flow:   Overall Study
    Donepezil  
STARTED     370  
COMPLETED     304  
NOT COMPLETED     66  
Death                 4  
Adverse Event                 30  
Lost to Follow-up                 4  
Withdrawal by Subject                 17  
Family wanted meds stopped                 1  
Family does not want continuation                 1  
Patient forgot to take meds                 1  
Does not meet entrance criteria                 1  
Physician Decision                 1  
Family discontinued meds                 1  
patient took for 2 days then stopped                 1  
patient never took the medication                 1  
hospitalized due to deterioration                 1  
week 12 not done                 1  
Syndrome De Glissement                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Donepezil As per physician prescription

Baseline Measures
    Donepezil  
Number of Participants  
[units: participants]
 		  370  
Age  
[units: years]
Mean ± Standard Deviation 		  80.1  ± 7.5  
Gender  
[units: participants]
 		 
Female     172  
Male     198  



  Outcome Measures
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1.  Primary:   All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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2.  Primary:   All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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3.  Primary:   All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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4.  Primary:   All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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5.  Primary:   All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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6.  Primary:   All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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7.  Primary:   All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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8.  Primary:   All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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9.  Primary:   All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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10.  Primary:   All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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11.  Primary:   All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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12.  Primary:   All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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13.  Primary:   All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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14.  Primary:   All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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15.  Primary:   All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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16.  Primary:   All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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17.  Primary:   All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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18.  Primary:   All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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19.  Primary:   All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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20.  Primary:   All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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21.  Primary:   All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment   [ Time Frame: Baseline and Week 12 ]
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22.  Secondary:   Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12   [ Time Frame: baseline, Week 12 ]
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23.  Secondary:   Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12   [ Time Frame: baseline, Week 12 LOCF ]
  Show Outcome Measure 23

24.  Secondary:   Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score   [ Time Frame: baseline, 12 Weeks ]
  Show Outcome Measure 24

25.  Secondary:   Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score   [ Time Frame: baseline, Week 12 LOCF ]
  Show Outcome Measure 25

26.  Secondary:   Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores   [ Time Frame: baseline, 12 Weeks ]
  Show Outcome Measure 26

27.  Secondary:   LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores   [ Time Frame: baseline, 12 Week LOCF ]
  Show Outcome Measure 27

28.  Secondary:   Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: baseline, 12 Weeks ]
  Show Outcome Measure 28

29.  Secondary:   Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: baseline, 12 Weeks LOCF ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)   [ Time Frame: baseline, 12 Weeks ]
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31.  Secondary:   LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)   [ Time Frame: baseline, 12 Weeks LOCF ]
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32.  Secondary:   Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire   [ Time Frame: baseline, 12 Weeks ]
  Show Outcome Measure 32

33.  Secondary:   LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire   [ Time Frame: baseline, 12 Weeks LOCF ]
  Show Outcome Measure 33

34.  Secondary:   Change From Baseline in Subject's Mobility at Week 12   [ Time Frame: baseline, 12 Weeks ]
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35.  Secondary:   Change From Baseline in Subject's Mobility at Week 12 LOCF   [ Time Frame: Week 12 LOCF ]
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36.  Secondary:   Change From Baseline in Subject's Self-Care at Week 12   [ Time Frame: baseline, Week 12 ]
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37.  Secondary:   Change From Baseline in Subject's Self-Care at Week 12 LOCF   [ Time Frame: baseline, 12 Weeks LOCF ]
  Show Outcome Measure 37

38.  Secondary:   Change From Baseline in Subject's Usual Activities at Week 12   [ Time Frame: baseline, Week 12 ]
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39.  Secondary:   Change From Baseline in Subject's Usual Activities at Week 12 LOCF   [ Time Frame: baseline, 12 Weeks LOCF ]
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40.  Secondary:   Change From Baseline in Subject's Pain/Discomfort at Week 12   [ Time Frame: baseline, Week 12 ]
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41.  Secondary:   Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF   [ Time Frame: Week 12 LOCF ]
  Show Outcome Measure 41

42.  Secondary:   Change From Baseline in Subject's Anxiety/Depression at Week 12   [ Time Frame: baseline, Week 12 ]
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43.  Secondary:   Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF   [ Time Frame: baseline, Week 12 LOCF ]
  Show Outcome Measure 43


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00843115     History of Changes
Other Study ID Numbers: NRA2500065, ECO STUDY
Study First Received: February 12, 2009
Results First Received: April 8, 2009
Last Updated: July 10, 2009
Health Authority: Canada: Health Canada