Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02079909
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2014-03-04
Brief Title:
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimers Disease US202
Sponsor:
FUJIFILM Toyama Chemical Co Ltd
Organization:
FUJIFILM Toyama Chemical Co Ltd
Study Overview
Official Title:
A Phase 2 Multi-center Randomized Double Blind Placebo-controlled Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC
The secondary objectives are
To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories physical examinations ECGs and solicitation of adverse events
To evaluate the efficacy of T-817MA as measured by ADCS-ADL FAQ Neuropsychiatric Inventory NPI and Mini-mental State Examination MMSE
The secondary objectives are
To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories physical examinations ECGs and solicitation of adverse events
To evaluate the efficacy of T-817MA as measured by ADCS-ADL FAQ Neuropsychiatric Inventory NPI and Mini-mental State Examination MMSE
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