To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.
The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
149
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
Time frame: Baseline, week 12, week 24
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.
Time frame: Baseline, week 12, week 24
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance \& correspondence, medications, leisure \& housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered
Time frame: Baseline, 12 weeks, 24 weeks
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.
Time frame: Baseline, week 12, week 24
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.
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Pfizer Investigational Site
Belvedere, Alberta, Canada
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Abbotsford British Columbia, British Columbia, Canada
Pfizer Investigational Site
Coquitlam, British Columbia, Canada
Pfizer Investigational Site
Victoria, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Saint John, New Brunswick, Canada
Pfizer Investigational Site
Amherst Nova Scotia, Nova Scotia, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
...and 20 more locations
Time frame: Baseline, 12 weeks, 24 weeks
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.
Time frame: Baseline, 12 weeks, 24 weeks
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.
Time frame: Baseline, 12 weeks, 24 weeks
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
The number of words a particpant can generate in 1 minute.
Time frame: Baseline, 12 weeks, week 24
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
NPI-Q measures severity of behavioural manifestations of dementia \& the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores \& ranges from 0 to 36
Time frame: Baseline, 12 weeks, 24 weeks
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60
Time frame: Baseline, week 12, week 24
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Scale measures subject's clinical condition at baseline for severity (CGI-S) \& for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) \& 4 indicates no change from baseline
Time frame: Baseline, week 24
Clinical Global Impressions Severity (CGI-S)
Scale measures subject's clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).
Time frame: Baseline
Clinical Global Impressions Improvement (CGI-I)
Scale measures subject's clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) \& 4 indicates no change from baseline
Time frame: Week (wk) 24
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Scale measures subject's (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more
Time frame: Baseline, week 24