Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02982603
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 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.
Study:
NCT02982603
Study Brief:
Protocol Section:
NCT02982603