Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease

Summary

This study will investigate the safety and efficacy of a Tyrosine Kinase Inhibitor (TKI) called Nilotinib BE (bioequivalent) in individuals with Early Alzheimer's disease (EAD). This is a multi-center double blinded, Phase 3 study, that will enroll patients for three years in approximately 50 centers nationwide. The total duration of the study will be for five years.

Timeline

Start

2022-02-01

Primary completion

2025-12-31

Completion

2026-06-01

Publications

• Background Turner RS, Hebron ML, Lawler A, Mundel EE, Yusuf N, Starr JN, Anjum M, Pagan F, Torres-Yaghi Y, Shi W, Mulki S, Ferrante D, Matar S, Liu X, Esposito G, Berkowitz F, Jiang X, Ahn J, Moussa C. Nilotinib Effects on Safety, Tolerability, and Biomarkers in Alzheimer's Disease. Ann Neurol. 2020 Jul;88(1):183-194. doi: 10.1002/ana.25775. Epub 2020 May 28.

Drugs

Indications