Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669028
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2020-12-04
Brief Title:
A Phase 3 Study of NE3107 in Probable Alzheimers Disease
Sponsor:
BioVie Inc
Organization:
BioVie Inc
Study Overview
Official Title:
A Phase 3 Double Blind Randomized Placebo Controlled Parallel Group Multicenter Study of NE3107 in Subjects Who Have Mild to Moderate Probable Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2023-11
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:
US multicenter parallel group study designed to evaluate the safety and efficacy of oral 20 mg twice daily BID NE3107 vs placebo in 400 adult subjects with mild to moderate probable AD Dual co-primary endpoints Clinical Dementia Rating Scale Sum of Boxes CDR-SB and ADAS-Cog12 will be evaluated as the change from Baseline to Week 30 Secondary endpoints include measures of cognition neuropsychological deficits functional performance and glycemic control A subset of patients may volunteer for exploratory magnetic resonance imaging volumetric changes and positron emission tomography cortical glucose metabolic rate scans at baseline and week 30
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None