Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02982603
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2016-11-30
Brief Title:
Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment
Sponsor:
Dongzhimen Hospital Beijing
Organization:
Dongzhimen Hospital Beijing
Study Overview
Official Title:
The Efficacy and Safety of Qinggongshoutao Bolus for aMnestic Mild Cognitive Impairment A 52- Week Randomized Double-blind ControlledThree Arms Multi-center Study
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 time2 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 Alzheimers 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 ExaminationMMSE Delayed Story RecallDSR Alzheimers Disease Cooperative StudyActivities of Daily Living scale adapted for MCI patients ADCSMCIADL24 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None