BAN2401 for Early Dementia and Mild Cognitive Impairment Study

This phase 2, placebo-controlled, double-blind, parallel-group, bayesian adaptive randomized design and dose regimen-finding study to evaluate safety, tolerability and efficacy of BAN2401 in subjects with early dementia Alzheimer’s disease and Mild Cognitive Impairment.

The study drug is called BAN2401, a humanized monoclonal antibody that targets amyloid beta.

You may be eligible for the study if you:

Are 50 to 90 years old
Have a diagnosis of Mild Cognitive impairment (MCI) or
Have a diagnosis of very early Alzheimer’s disease
Have a caregiver who can accompany you for some of the study visits

What happens during the study?

A telephone screening will be conducted to determine if you are eligible to come in for an in-person screening visit. This screening visit will determine if you are eligible to participate in the study.

As part of the screening procedures, you will have a MRI and a PET scan using Amyvid, an FDA-approved compound to determine the presence or absence of amyloid deposits in the brain.

If you are eligible, you will be enrolled in the study and receive either study drug BAN2401 or placebo intravenously every two weeks for a period of 18 months.

You will have tests of memory to assess the effects of the study drug, along with MRIs, physical examinations and EKGs to assess for drug safety.

Where is this study taking place?

Boston University Medical Center

Meet the team

Robert A. Stern, PhD – Principal Investigator
Wendy Qiu, MD, PhD – Study Physician
Jesse Mez, MD – Study Physician
Jane Mwicigi, MPH – Study Coordinator
Dawn Jacobs, MPH – Clinical Research Coordinator

More information

Please call (617) 358-5382 or email JoinADC@bu.edu for more information and to participate.

Sponsor – Eisai, Inc