NCT03179501

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

Effect of Single Dose NP001 on Blood Markers of Inflammation in Individuals With Mild-to-Moderate Alzheimer's Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Beau Nakamoto · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Abnormal inflammatory monocytes/macrophages, systemically and locally in the central nervous system (CNS), are implicated in the neuro-inflammatory process seen in Alzheimer's disease. NP001 is a novel immune regulator of inflammatory monocytes/macrophages. Given the key role inflammatory monocytes/macrophages may play in the pathogenesis of AD, this study will assess the changes in inflammatory monocyte-associated biomarkers, including CD16 and HLA-DR, pre- and post- NP001. This is a Phase 1 single-site, randomized, double-blind, placebo-controlled pilot biomarker study of a single dose of NP001 in individuals with mild-to-moderate Alzheimer's disease. Fourteen individuals will be enrolled and randomized 1:1 to NP001 and placebo. Drug or placebo will be given intravenously. Biomarkers will be measured at baseline and 1 and 7 days following infusion.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	NP001	NP001
DRUG	Placebo	Normal saline

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2017-06-07
• Last updated: 2018-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study