Loading clinical trials...
Loading clinical trials...
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease
The purpose of the study is to evaluate the safety and tolerability of multiple doses of NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics of multiple doses of NPT088.
This study is a multicenter Phase 1, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation safety and tolerability study of NPT088 or placebo in patients with Probable AD with a MMSE score of 16-27. Enrolled patients will receive an intravenous infusion of NPT088 or placebo once a month for six months during this study. Four dose cohorts are planned with the first two cohorts enrolling 9 patients each (6 NPT088: 3 placebo) and the final two cohorts enrolling 24 patients each (16 NPT088: 8 placebo) for a total of 66 patients (44 NPT088: 22 placebo).
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Collaborative Neuroscience Network
Long Beach, California, United States
Southern California Research
Simi Valley, California, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Start Date
December 1, 2016
Primary Completion Date
February 6, 2019
Completion Date
February 6, 2019
Last Updated
August 15, 2019
83
ACTUAL participants
NPT088
DRUG
Placebo
DRUG
Lead Sponsor
Proclara Biosciences, Inc.
Collaborators
NCT07178210
NCT04123314
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions