Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02386306
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2015-02-16
Brief Title:
Study Evaluating Safety Tolerability and PK of Multiple Ascending Doses of GC021109 in Subjects With Mild to Moderate Alzheimers Disease
Sponsor:
GliaCure Inc
Organization:
GliaCure Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 1b Safety Tolerability and Pharmacokinetic Study of Multiple Ascending Doses of GC021109 in Subjects With Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2015-07
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:
This is a Phase 1b multi-center randomized double-blind placebo-controlled study designed to evaluate the safety tolerability and pharmacokinetics of GC021109 in subjects with mild to moderate Alzheimers Disease as determined by 2011 National Institute on Aging- Alzheimers Association NIA-AA criteria and Mini Mental State Examination MMSE The Investigator study site staff with exception of a designated pharmacistpharmacy technician and all study subjects will be blinded to randomized study medication assignment until database lock Treatment assignments may be unblinded for select pre-authorized individuals involved in the safety and PK data reviews in order to accurately determine how to proceed with dose escalation
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