NP001, Alzheimer's Disease, and Blood Markers of Inflammation
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|ClinicalTrials.gov Identifier: NCT03179501|
Recruitment Status : Terminated (Poor recruitment)
First Posted : June 7, 2017
Last Update Posted : October 22, 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)|
|Actual Enrollment :||4 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|
|Actual Primary Completion Date :||July 31, 2018|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179501
|United States, Hawaii|
|University of Hawaii Clinics at Kakaako|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Beau Nakamoto, MD PhD||University of Hawaii|