Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease
- Registration Number
- NCT03008161
- Lead Sponsor
- Proclara Biosciences, Inc.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
For enrollment in the study, participants must
- be between 50 and 85 years of age, inclusive
- have a Mini Mental State Examination (MMSE) scores between 16-27 (inclusive)
- have a Modified Hachinski Score of less than or equal to 4
- have a diagnosis of Probable Alzheimer's Disease (AD) according to consensus criteria defined by the National Institute on Aging-Alzheimer's Association work group
- have a Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0, with the memory box score equal to or greater than 0.5
- have a positive florbetapir positron emission tomography (PET) amyloid scan
- consent to apolipoprotein E (ApoE) genotyping
- be willing to undergo repeat Magnetic Resonance Imaging (MRI) and PET imaging
- be on stable doses of allowed medications for at least 30 days prior to Screening. Concurrent treatment with cholinesterase inhibitors and/or memantine is allowed
- be in good healthy apart from the clinical diagnosis of AD
- have a dedicated Caregiver who provides care at least 4 hours a day for 4 days a week and will provide informed consent for their participation
For enrollment in the study, participants must NOT:
- have a history of, or screening MRI indicative of any significant brain abnormality
- have any major medical illness or unstable medical condition or in the opinion of the Investigator have any reason that may interfere with the participants ability to comply with the study procedures and abide by study restrictions or with the ability to interpret safety data
- reside in a nursing home or need 24-hour care and supervision
- take excluded medications
- have exclusionary values on the Screening blood and urine sample
- have been treated with immunomodulators to treat AD
- have participated in an investigational drug or device study within 90 days
- have a known allergy to study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 NPT088 Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months Cohort 4 Placebo Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months Cohort 1 Placebo Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months Cohort 2 Placebo Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months Cohort 3 Placebo Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months Cohort 4 NPT088 Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months Cohort 1 NPT088 Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months Cohort 2 NPT088 Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months
- Primary Outcome Measures
Name Time Method Number of patients with adverse events Baseline to Week 32
- Secondary Outcome Measures
Name Time Method Multiple dose PK CSF concentrations of NPT088 Up to Week 32 Multiple dose pharmacokinetic (PK) serum concentrations of NPT088 Up to Week 32 Multiple dose immunogenicity of NPT088 Up to Week 32
Trial Locations
- Locations (23)
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
NeuroStudies LLC
🇺🇸Decatur, Georgia, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Alzheimer's Research and Treatment Center
🇺🇸Lake Worth, Florida, United States
Southern California Research
🇺🇸Simi Valley, California, United States
Collaborative Neuroscience Network
🇺🇸Long Beach, California, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Associated Neurologists of Southern Connecticut
🇺🇸Fairfield, Connecticut, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Compass-The Villages
🇺🇸The Villages, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Medical Research and Health Education Foundation
🇺🇸Columbus, Georgia, United States
Integrative Clinical Trials, Inc.
🇺🇸Brooklyn, New York, United States
Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
Abington Neurological Associates, Ltd
🇺🇸Willow Grove, Pennsylvania, United States
Neurology Clinic, PC
🇺🇸Cordova, Tennessee, United States
Neurological Associates of Albany
🇺🇸Albany, New York, United States
Compass Research
🇺🇸Orlando, Florida, United States
Axiom Clinical Research
🇺🇸Tampa, Florida, United States