Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

Summary

This study will assess the effects of VX-745 on markers of disease in the central nervous system of patients with MCI due to AD or with mild AD. The study will also evaluate the safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the plasma and cerebrospinal fluid concentrations of VX-745 during dosing.

Timeline

Start

2015-04

Primary completion

2016-09

Completion

2016-11

Outcome

Met primary endpoint

release “Statistically significant improvement in tests of episodic memory and learning; as assessed by Wechsler Memory Scale (WMS)” cervomed.com ↗

release “the two clinical trials met their primary objectives by demonstrating disease-relevant pharmacologic activity” cervomed.com ↗

Publications

• Tormahlen NM, Martorelli M, Kuhn A, Maier F, Guezguez J, Burnet M, Albrecht W, Laufer SA, Koch P. Design and Synthesis of Highly Selective Brain Penetrant p38alpha Mitogen-Activated Protein Kinase Inhibitors. J Med Chem. 2022 Jan 27;65(2):1225-1242. doi: 10.1021/acs.jmedchem.0c01773. Epub 2021 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neflamapimod	Small molecule	—	Oral

Indications