NP001, Alzheimer's Disease, and Blood Markers of Inflammation

Summary

This is a Phase 1 placebo-controlled biomarker study of NP001 in individuals with Alzheimer's Disease.

Timeline

Start

2017-09-01

Primary completion

2018-07-31

Completion

2018-07-31

Outcome

Outcome not reported

Stopped (Enrollment): “Poor recruitment”

Publications

• Background Miller RG, Block G, Katz JS, Barohn RJ, Gopalakrishnan V, Cudkowicz M, Zhang JR, McGrath MS, Ludington E, Appel SH, Azhir A; Phase 2 Trial NP001 Investigators. Randomized phase 2 trial of NP001-a novel immune regulator: Safety and early efficacy in ALS. Neurol Neuroimmunol Neuroinflamm. 2015 Apr 9;2(3):e100. doi: 10.1212/NXI.0000000000000100. eCollection 2015 Jun.
• Background Miller RG, Zhang R, Block G, Katz J, Barohn R, Kasarskis E, Forshew D, Gopalakrishnan V, McGrath MS. NP001 regulation of macrophage activation markers in ALS: a phase I clinical and biomarker study. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):601-9. doi: 10.3109/21678421.2014.951940. Epub 2014 Sep 5.
• Background Zhang R, Miller RG, Madison C, Jin X, Honrada R, Harris W, Katz J, Forshew DA, McGrath MS. Systemic immune system alterations in early stages of Alzheimer's disease. J Neuroimmunol. 2013 Mar 15;256(1-2):38-42. doi: 10.1016/j.jneuroim.2013.01.002. Epub 2013 Feb 4.
• Background Pey P, Pearce RK, Kalaitzakis ME, Griffin WS, Gentleman SM. Phenotypic profile of alternative activation marker CD163 is different in Alzheimer's and Parkinson's disease. Acta Neuropathol Commun. 2014 Feb 14;2:21. doi: 10.1186/2051-5960-2-21.

Drugs

Indications