Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02982642
Status:
WITHDRAWN
Last Update Posted:
2021-03-04
First Post:
2016-12-01
Brief Title:
Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment
Sponsor:
Dongzhimen Hospital Beijing
Organization:
Dongzhimen Hospital Beijing
Study Overview
Official Title:
The Safety and Efficacy of 1612 Capsules in Treatment of aMnestic Mild Cognitive Impairment a 52-week Double BlindRandomized ParallelPlacebo Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor cannot conduct research due to insufficient funding supportment
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 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 114g 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 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 Examination MMSE Delayed Story Recall test DSR 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