Title: A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer’s DiseaseStudy Identifier: 2013-011, Athena AD studyPrincipal Investigator: Yuval Zabar, MD
Sponsor: Eisai Inc.
Purpose: The purpose of this study is to determine if the study drug (BAN2401) is safe and effective in subjects with Mild Cognitive Impairment due to Alzheimer’s disease or mild Alzheimer’s disease.
Summary: This study is being conducted to find out if the study drug (BAN 2401) has a beneficial effect on a person’s cognitive (ability to think and remember) status using a series of specialized cognitive (memory and reasoning) tests. The purpose of this research is also to find out if this study drug is safe and well-tolerated.
People with Alzheimer’s disease have a build-up of abnormal protein known as amyloid in their brains. The study drug, BAN2401, is thought to reduce the amount of this abnormal protein.
Study participants who agree to be in this clinical trial and who meet all of the study entry requirements will be assigned by chance (like flipping a coin) into one of 6 treatment groups. Treatment for this study is either the study drug (at varying doses) or placebo. A placebo looks the same as the study drug but has no active study drug ingredients in it (like a sugar pill). A placebo is used to help see what outcome, if any; the study drug may have (both good and/or bad). All study medication (either BAN2401 or placebo) will be given the same way: intravenous (IV) infusion into a vein in the arm. Infusions will occur every 2 weeks for 18 months and will take place at Lahey Hospital & Medical Center, Burlington.
The study also includes several Magnetic Resonance Imagining (MRI) brain scans, Electrocardiograms (ECGs), and collection of blood samples to monitor for study drug effects.
Study Type: Interventional
Length/Duration: Study participation will last approximately 23 months and include approximately 44 visits. All of these visits will occur at Lahey Hospital & Medical Center, Burlington. Some of these visits will require the presence of a caregiver or informant (somebody who can answers questions about the study participant’s memory).
ELIGIBILITY: If you are interested in this study and want to see if you or your loved one may qualify for this study, click here, to complete a brief eligibility form.
Contact: For more information on this study, please contact the study coordinator at Nicholas.F.Ventura@Lahey.org or 781-744-3216.
Clinical Trials.gov Identifier: NCT 01767311