A Phase 3 Study of NE3107 in Probable Alzheimer's Disease

Status Completed

Clinical Trial Summary

U.S. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Alzheimer Disease

Clinical Trial Details

NCT number	NCT04669028
Study type	Interventional
Source	BioVie Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	August 5, 2021
Completion date	October 25, 2023

View Details

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