Clinical trial NCT00843115: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease, naturalistic study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 370
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's Disease with or without other etiologies of dementia

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.

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

Primary outcomes:
measure: All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
measure: All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
timeFrame: baseline, Week 12
measure: Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
timeFrame: baseline, Week 12 LOCF
measure: 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
timeFrame: baseline, 12 Weeks
measure: 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
timeFrame: baseline, Week 12 LOCF
measure: Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
timeFrame: baseline, 12 Weeks
measure: LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
timeFrame: baseline, 12 Week LOCF
measure: 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)
timeFrame: baseline, 12 Weeks
measure: 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)
timeFrame: baseline, 12 Weeks LOCF
measure: Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
timeFrame: baseline, 12 Weeks
measure: LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
timeFrame: baseline, 12 Weeks LOCF
measure: Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire
timeFrame: baseline, 12 Weeks
measure: LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire
timeFrame: baseline, 12 Weeks LOCF
measure: Change From Baseline in Subject's Mobility at Week 12
timeFrame: baseline, 12 Weeks
measure: Change From Baseline in Subject's Mobility at Week 12 LOCF
timeFrame: Week 12 LOCF
measure: Change From Baseline in Subject's Self-Care at Week 12
timeFrame: baseline, Week 12
measure: Change From Baseline in Subject's Self-Care at Week 12 LOCF
timeFrame: baseline, 12 Weeks LOCF
measure: Change From Baseline in Subject's Usual Activities at Week 12
timeFrame: baseline, Week 12
measure: Change From Baseline in Subject's Usual Activities at Week 12 LOCF
timeFrame: baseline, 12 Weeks LOCF
measure: Change From Baseline in Subject's Pain/Discomfort at Week 12
timeFrame: baseline, Week 12
measure: Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF
timeFrame: Week 12 LOCF
measure: Change From Baseline in Subject's Anxiety/Depression at Week 12
timeFrame: baseline, Week 12
measure: Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF
timeFrame: baseline, Week 12 LOCF
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: