Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) |
The VaDAS-cog comprises the Alzheimer's disease assessment scale(ADAS-cog) plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 52. |
Change from baseline VaDAS-cog score at Week 52 |
|
| Primary |
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) |
The Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration). |
Change from baseline ADCS-CGIC score at Week 52 |
|
| Secondary |
Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL) |
To assess the daily living activity of the patients, including a subgroup in which there are 23 items to be checked and the total score is 78. A higher score represents a better daily living activity, vice versa. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean,SD) of precise scores at week 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline ADCS-ADL score at Week 26 |
|
| Secondary |
Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL) |
To assess the daily living activity of the patients, including a subgroup in which there are 23 items to be checked and the total score is 78. A higher score represents a better daily living activity, vice versa. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean,SD) of precise scores at week 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline ADCS-ADL score at Week 52 |
|
| Secondary |
Mini-mental State Examination(MMSE) |
The MMSE is a global test of cognitive function, for which the total score ranges from 0 to 30, with higher scores indicating lesser severity. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean, SD) of precise scores at screening (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline MMSE score at Week 26 |
|
| Secondary |
Mini-mental State Examination(MMSE) |
The MMSE is a global test of cognitive function, for which the total score ranges from 0 to 30, with higher scores indicating lesser severity. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean, SD) of precise scores at screening (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline MMSE score at Week 52 |
|
| Secondary |
Clinical Dementia Rating(CDR Scale ) |
The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Talk to the patients or those who know well about the patients and assess the 6 functions (memory, orientation, judgment and problem-solving ability, social activities, household duties and hobbies as well as self-care ability) to obtain the scores and based on the predetermined principles the CDR score is calculated. The diagnostic criteria[68]: normal-CDR=0; suspected dementia-CDR=0.5, mild dementia-CDR=1; moderate dementia- CDR=2; and serious dementia-CDR=3. The data in the table below is the statistical data (mean, SD) of precise scores at baseline and weeks 26. |
Change from baseline CDR Scale score at Week 26 |
|
| Secondary |
Clinical Dementia Rating(CDR Scale ) |
The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Talk to the patients or those who know well about the patients and assess the 6 functions (memory, orientation, judgment and problem-solving ability, social activities, household duties and hobbies as well as self-care ability) to obtain the scores and based on the predetermined principles the CDR score is calculated. The diagnostic criteria[68]: normal-CDR=0; suspected dementia-CDR=0.5, mild dementia-CDR=1; moderate dementia- CDR=2; and serious dementia-CDR=3. The data in the table below is the statistical data (mean, SD) of precise scores at baseline and weeks 52. |
Change from baseline CDR Scale score at Week 52 |
|
| Secondary |
Clinical Dementia Rating sum of boxes(CDR-sb) |
CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment. CDR-sb is the algebraic sum of 6 functional domains with a range of 0(normal) - 18(severe dementia). The data in the table below is the statistical data (mean,SD) of precise scores at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline CDR-sb score at Week 26 |
|
| Secondary |
Clinical Dementia Rating sum of boxes(CDR-sb) |
CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment. CDR-sb is the algebraic sum of 6 functional domains with a range of 0(normal) - 18(severe dementia). The data in the table below is the statistical data (mean,SD) of precise scores at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline CDR-sb score at Week 52 |
|
| Secondary |
Blood biomarker: Brain-derived neurotrophic factor(BDNF) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline BDNF at Week 26 |
|
| Secondary |
Blood biomarker: Brain-derived neurotrophic factor(BDNF) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0(baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline BDNF at Week 52 |
|
| Secondary |
Blood biomarker: Vascular endothelial growth factor(VEGF) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline VEGF at Week 26 |
|
| Secondary |
Blood biomarker: Vascular endothelial growth factor(VEGF) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline VEGF at Week 52 |
|
| Secondary |
Blood biomarker: Matrix metalloproteinase-9(MMP-9) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline MMP-9 at Week 26 |
|
| Secondary |
Blood biomarker: Matrix metalloproteinase-9(MMP-9)) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline MMP-9 at Week 52 |
|
| Secondary |
Blood biomarker: Interleukin-6(IL-6) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26. |
Change from baseline MMP-9 at Week 26 |
|
| Secondary |
Blood biomarker: Interleukin-6(IL-6) |
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52. |
Change from baseline MMP-9 at Week 52 |
|
| Secondary |
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) |
The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 13. |
Change from baseline VaDAS-cog score at week 13 |
|
| Secondary |
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) |
The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 26. |
Change from baseline VaDAS-cog score at week 26 |
|
| Secondary |
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) |
The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 39. |
Change from baseline VaDAS-cog score at week 39 |
|
| Secondary |
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) |
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration). |
Change from baseline ADCS-CGIC score at week 13 |
|
| Secondary |
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) |
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration). |
Change from baseline ADCS-CGIC score at week 26 |
|
| Secondary |
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) |
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration). |
Change from baseline ADCS-CGIC score at week 39 |
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