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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Number of patients with adverse events
Time frame: Baseline to Week 32
Multiple dose pharmacokinetic (PK) serum concentrations of NPT088
Time frame: Up to Week 32
Multiple dose PK CSF concentrations of NPT088
Time frame: Up to Week 32
Multiple dose immunogenicity of NPT088
Time frame: Up to Week 32
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 13 more locations