Trial Summary
Official Title
A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PMN310 in Patients With Early Alzheimer's Disease
Status
Recruiting
Condition
Alzheimer's Disease, Early Alzheimer's Disease
Actual Start Date
December 2024
Additional Information
About The Trial
PMN310 in Patients with Early Alzheimer's Disease (PRECISE-AD)
This study is a Phase 1b, randomized, double-blind, placebo-controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (5 mg/kg, 10mg/kg, and 20 mg/kg are planned). Patients will be randomly assigned 3:1, PMN310: placebo.
Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.
Locations
The following cities have PRECISE-AD clinical trial sites. Please check back often as locations will be updated.
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Irvine Center for Clinical Research
Irvine, California, United States, 92614 -
Healthy Brain Research
Long Beach, California, United States, 90804 -
JEM Research Institute
Atlantis, Florida, United States, 33462 -
Quantum Laboratories
Deerfield Beach, Florida, United States, 33442 -
Brain Matters Research
Delray Beach, Florida, United States, 33445 -
Finlay Medical Research
Miami, Florida, United States, 33126 -
Gonzalez MD and Aswad MD Health Services, Optimus U Corp
Miami, Florida, United States, 33135 -
Renstar Medical Research
Ocala, Florida, United States, 34470 -
Charter Research
Orlando, Florida, United States, 32803 -
Alzheimer's Research and Treatment Center
Stuart, Florida, United States, 34997 -
Charter Research
The Villages, Florida, United States, 32162 -
Alzheimer's Research and Treatment Center
Wellington, Florida, United States, 33414 -
Conquest Research, LLC
Winter Park, Florida, United States, 32789 -
Columbus Memory Center, LLC
Columbus, Georgia, United States, 31909 -
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030 -
Headlands Eastern MA LLC
Plymouth, Massachusetts, United States, 02360 -
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States, 08755 -
Alzheimer's Disease Research Center
Albany, New York, United States, 12208 -
Flourish Research
Matthews, North Carolina, United States, 28105 -
Neuro Behavioral Clinical Research, Inc.
North Canton, Ohio, United States, 44720 -
Keystone Clinical Studies, LLC
Plymouth Meeting, Pennsylvania, United States, 19462 -
Kerwin Medical Center
Dallas, Texas, United States, 75231
Frequently Asked Questions
Why is this trial being done?
This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.
How many people will participate in this trial?
The estimated enrollment for this trial is approximately 128 patients.
What is PMN310?
Please click here to learn more about PMN310.
The safety and efficacy of this investigational product have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.