NP001, Alzheimer's Disease, and Blood Markers of Inflammation
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single-site, randomized, double-blind, placebo-controlledMasking: Participant, Care Provider, Investigator, Outcomes Assessor
Double-blindPrimary Purpose: Basic Science
|Official Title:||Effect of Single Dose NP001 on Blood Markers of Inflammation in Individuals With Mild-to-Moderate Alzheimer's Disease|
- Inflammatory monocyte-associated biomarkers [ Time Frame: 7 days ]The primary endpoint is changes from baseline at 1 and 7 days following dosing in percent monocyte expression levels of CD16 and HLA-DR.
- Adverse Events [ Time Frame: 7 days ]The secondary endpoint is reported and observed adverse events following dosing and at 1 and 7 days post-infusion.
|Anticipated Study Start Date:||August 1, 2017|
|Estimated Study Completion Date:||December 31, 2017|
|Estimated Primary Completion Date:||December 31, 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03179501
|Contact: Debbie Ogata-Arakaki, RNfirstname.lastname@example.org|
|Contact: Beau Nakamoto, MD PhDemail@example.com|
|Principal Investigator:||Beau Nakamoto, MD PhD||University of Hawaii|