Observational Study Of Donepezil In Routine Clinical Practice

This study has been terminated.
(See Detailed Description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00843115
First received: February 12, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Other: donepezil
Phase 4

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Ecological Perspective On The Efficacy And Tolerability Of Donepezil In A Routine Clinical Practice: A Patient Centered Observational Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3

  • All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.

  • All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.


Secondary Outcome Measures:
  • Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12 [ Time Frame: baseline, Week 12 ] [ Designated as safety issue: No ]
    MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.

  • 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 ] [ Designated as safety issue: No ]
    MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline

  • 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 ] [ Designated as safety issue: No ]
    MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.

  • 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 ] [ Designated as safety issue: No ]
    MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver

  • 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 ] [ Designated as safety issue: No ]
    Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.

  • 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 ] [ Designated as safety issue: No ]
    Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.

  • 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 ] [ Designated as safety issue: No ]
    QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.

  • 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 ] [ Designated as safety issue: No ]
    QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.

  • Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D) [ Time Frame: baseline, 12 Weeks ] [ Designated as safety issue: No ]
    EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score

  • LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D) [ Time Frame: baseline, 12 Weeks LOCF ] [ Designated as safety issue: No ]
    EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score

  • 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 ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.

  • 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 ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.

  • Change From Baseline in Subject's Mobility at Week 12 [ Time Frame: baseline, 12 Weeks ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.

  • Change From Baseline in Subject's Mobility at Week 12 LOCF [ Time Frame: Week 12 LOCF ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with "any problem" at baseline versus Week 12 LOCF

  • Change From Baseline in Subject's Self-Care at Week 12 [ Time Frame: baseline, Week 12 ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12

  • Change From Baseline in Subject's Self-Care at Week 12 LOCF [ Time Frame: baseline, 12 Weeks LOCF ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12 LOCF.

  • Change From Baseline in Subject's Usual Activities at Week 12 [ Time Frame: baseline, Week 12 ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.

  • Change From Baseline in Subject's Usual Activities at Week 12 LOCF [ Time Frame: baseline, 12 Weeks LOCF ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12 LOCF

  • Change From Baseline in Subject's Pain/Discomfort at Week 12 [ Time Frame: baseline, Week 12 ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.

  • Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF [ Time Frame: Week 12 LOCF ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with "any problem" at baseline versus Week 12 LOCF

  • Change From Baseline in Subject's Anxiety/Depression at Week 12 [ Time Frame: baseline, Week 12 ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.

  • Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF [ Time Frame: baseline, Week 12 LOCF ] [ Designated as safety issue: No ]
    EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with "any problem" and "no problem" at baseline versus at Week 12 LOCF


Enrollment: 370
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
This study was non-interventional and simply followed for 3 months patients initiating a treatment with donepezil
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

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.

  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

Patients with Alzheimer's Disease with or without other etiologies of dementia

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843115

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
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: February 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Alzheimer's Disease, naturalistic study

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
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 July 31, 2014