Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment
Status:
Withdrawn
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.