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

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.

Timeline

Start

2021-08-05

Primary completion

2023-09-30

Completion

2023-10-25

Publications

• Background Reading CL, Ahlem CN, Murphy MF. NM101 Phase III study of NE3107 in Alzheimer's disease: rationale, design and therapeutic modulation of neuroinflammation and insulin resistance. Neurodegener Dis Manag. 2021 Aug;11(4):289-298. doi: 10.2217/nmt-2021-0022. Epub 2021 Jul 12.
• Reading CL, Yan J, Testa MA, Simonson DC, Javaid H, Schmunk L, Martin-Herranz DE, Brooke R, Gordevicius J, Zhang J, Yuan H, Ahlem C, Wang L, Markham P, Osman N, O'Quinn S, Palumbo J. An exploratory analysis of bezisterim treatment associated with decreased biological age acceleration, and improved clinical measure and biomarker changes in mild-to-moderate probable Alzheimer's disease. Front Neurosci. 2025 May 2;19:1516746. doi: 10.3389/fnins.2025.1516746. eCollection 2025.

Drugs

Indications