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Clinical Trial Summary

This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel trial which will be carried out in 15 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per day) or placebo 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 test (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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02982642
Study type Interventional
Source Dongzhimen Hospital, Beijing
Contact
Status Withdrawn
Phase Phase 4
Start date January 2017
Completion date December 2018

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