- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00843115
Observational Study Of Donepezil In Routine Clinical Practice
February 11, 2014 updated by: Pfizer
Ecological Perspective On The Efficacy And Tolerability Of Donepezil In A Routine Clinical Practice: A Patient Centered Observational Study
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.
Study Overview
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
Enrollment (Actual)
370
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Alzheimer's Disease with or without other etiologies of dementia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational
This study was non-interventional and simply followed for 3 months patients initiating a treatment with donepezil
|
Routine clinical practice of prescribing donepezil as per the Canadian label.
No drug was supplied as part of this study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Time Frame: Baseline and Week 12
|
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.
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
Time Frame: baseline, Week 12
|
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.
|
baseline, Week 12
|
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
|
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
|
baseline, Week 12 LOCF
|
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
|
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.
|
baseline, 12 Weeks
|
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
|
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
|
baseline, Week 12 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 Weeks
|
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.
|
baseline, 12 Weeks
|
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
|
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.
|
baseline, 12 Week LOCF
|
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
|
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.
|
baseline, 12 Weeks
|
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
|
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.
|
baseline, 12 Weeks LOCF
|
Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
Time Frame: baseline, 12 Weeks
|
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
|
baseline, 12 Weeks
|
LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
Time Frame: baseline, 12 Weeks LOCF
|
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
|
baseline, 12 Weeks 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
|
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.
|
baseline, 12 Weeks
|
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
|
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.
|
baseline, 12 Weeks LOCF
|
Change From Baseline in Subject's Mobility at Week 12
Time Frame: baseline, 12 Weeks
|
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.
|
baseline, 12 Weeks
|
Change From Baseline in Subject's Mobility at Week 12 LOCF
Time Frame: Week 12 LOCF
|
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
|
Week 12 LOCF
|
Change From Baseline in Subject's Self-Care at Week 12
Time Frame: baseline, Week 12
|
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
|
baseline, Week 12
|
Change From Baseline in Subject's Self-Care at Week 12 LOCF
Time Frame: baseline, 12 Weeks LOCF
|
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.
|
baseline, 12 Weeks LOCF
|
Change From Baseline in Subject's Usual Activities at Week 12
Time Frame: baseline, Week 12
|
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.
|
baseline, Week 12
|
Change From Baseline in Subject's Usual Activities at Week 12 LOCF
Time Frame: baseline, 12 Weeks LOCF
|
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
|
baseline, 12 Weeks LOCF
|
Change From Baseline in Subject's Pain/Discomfort at Week 12
Time Frame: baseline, Week 12
|
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.
|
baseline, Week 12
|
Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF
Time Frame: Week 12 LOCF
|
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
|
Week 12 LOCF
|
Change From Baseline in Subject's Anxiety/Depression at Week 12
Time Frame: baseline, Week 12
|
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.
|
baseline, Week 12
|
Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF
Time Frame: baseline, Week 12 LOCF
|
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
|
baseline, Week 12 LOCF
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (Estimate)
February 13, 2009
Study Record Updates
Last Update Posted (Estimate)
March 13, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- NRA2500065
- ECO STUDY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer's Disease
-
University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
-
University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
-
University of Colorado, DenverNational Institute on Aging (NIA)Active, not recruitingSuspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)United States
Clinical Trials on donepezil
-
Eisai Inc.Eisai LimitedCompleted
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Corium, Inc.CompletedAlzheimer DiseaseUnited States
-
Samsung Medical CenterEisai Korea Inc.CompletedDementia | Alzheimer's DiseaseKorea, Republic of
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.CompletedMigraine HeadacheUnited States
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Completed