Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Conditions
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Dementia, Vascular, Dementia, Mixed

Intervention / Treatment
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* Drug: Donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies. Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required. Exclusion Criteria: Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Donepezil<br>* donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, week 12, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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). | 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 | 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 | Baseline, week 24 |