NCT02982603

Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

The Efficacy and Safety of Qinggongshoutao Bolus for aMnestic Mild Cognitive Impairment: A 52- Week Randomized, Double-blind, Controlled,Three Arms, Multi-center Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Mild Cognitive Impairment
• Herbal Medicine Allergy

Interventions

Type	Name	Description
DRUG	Qinggongshoutao Bolus	Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761
DRUG	Ginkgo Biloba Extract 761	Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761
DRUG	Placebos	Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-12-05
• Last updated: 2018-10-23

Locations

1 site across 1 country: China