Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase VI trial being carried out in 20 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2 times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton) (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qinggongshoutao Bolus | Experimental | Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks. |
|
| Ginkgo Biloba Extract 761 | Active Comparator | Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks. |
|
| Placebos | Placebo Comparator | Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qinggongshoutao Bolus | Drug | Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale | week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52. | |
| Change from baseline to end of double-blind treatment of rate of conversion to dementia | week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination(MMSE) | week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52. | |
| Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR) | week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jinzhou Tian, M.D,PhD | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital ,Beijing University of Chinese Medicine | Beijing | Beijing Municipality | 100700 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C526713 | ginaton |
| C063170 | Ginkgo biloba extract |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ginkgo Biloba Extract 761 | Drug | Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761 |
|
|
| Placebos | Drug | Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba |
|
| Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) | week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52. |