| Primary | 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. | Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; Weeks 12, 24 n=124, 114 | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, week 12, week 24 | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
| | | Title | Denominators | Categories |
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| Week 12 (n=124) | | | | Week 24 (n=114) | | | | Week 24 LOCF (n=137) | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature. | Mixed Models Analysis | | 0.182 | Baseline value, center, and week as fixed effects; subject was included as a random effect. | Mean Difference (Net) | 0.44 | Standard Error of the Mean | 0.33 | | 95 | -0.21 | 1.09 | | | | No |
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| Secondary | 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. | Full Analysis Set (FAS): all subjects who received at least one dose of donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124, 114. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, week 12, week 24 | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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 | Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124,114 | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 12 weeks, 24 weeks | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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. | Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n = 124, 114 | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, week 12, week 24 | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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. | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; weeks 12, 24 n = 123, 111 | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, 12 weeks, 24 weeks | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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. | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF N=131; weeks 12, 24 n = 117, 106 | Posted | | Mean | Standard Deviation | Score on scale | | Baseline, 12 weeks, 24 weeks | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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. | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF N=131; weeks 12, 24 n = 117, 106 | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, 12 weeks, 24 weeks | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS) | The number of words a particpant can generate in 1 minute. | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=136; weeks 12, 24 n = 123, 113 | Posted | | Mean | Standard Deviation | score on scale | | Baseline, 12 weeks, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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 | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=137; weeks 12, 24 n = 124, 114 | Posted | | Mean | Standard Deviation | Score on scale | | Baseline, 12 weeks, 24 weeks | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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 | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114 | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, week 12, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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 | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. Subjects with Baseline = 136; week 24 n = 116; week 24 LOCF n = 136 | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, week 24 | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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). | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with a value | Posted | | Number | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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 | Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with value (Week 24 n=116; Week 24 LOCF n=136) | Posted | | Number | | Participants | | Week (wk) 24 | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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| Secondary | 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 | Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy. LOCF = Last Observation Carried Forward. Week 24 n=116; Week 24 LOCF n=136 | Posted | | Number | | Particpants | | Baseline, week 24 | | | | ID | Title | Description |
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| OG000 | Donepezil | Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks. |
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