NP001, Alzheimer's Disease, and Blood Markers of Inflammation
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|ClinicalTrials.gov Identifier: NCT03179501|
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: NP001 Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-site, randomized, double-blind, placebo-controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Single Dose NP001 on Blood Markers of Inflammation in Individuals With Mild-to-Moderate Alzheimer's Disease|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||July 31, 2018|
|Estimated Study Completion Date :||July 31, 2018|
Placebo Comparator: Placebo
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179501
|Contact: Debbie Ogata-Arakaki, RNfirstname.lastname@example.org|
|Contact: Beau Nakamoto, MD PhDemail@example.com|
|United States, Hawaii|
|University of Hawaii Clinics at Kakaako||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Debbie Ogata-Arakaki, RN 808-692-1310 firstname.lastname@example.org|
|Contact: Beau Nakamoto, MD, PhD 808-692-1310 email@example.com|
|Principal Investigator:||Beau Nakamoto, MD PhD||University of Hawaii|