EISAI BAN 2401 Campaign

WHAT IS THE PURPOSE OF THE STUDY?

To assess the safety and efficacy of the study drug, BAN2401, in patients who have early Alzheimer’s disease.

BAN2401 is a monoclonal antibody. Antibodies are proteins produced by the immune system that bind to foreign substances in the body called antigens.

BAN2401 binds to amyloid in the brain in patients with AD and has been shown to reduce the amount of this abnormal protein.

WHAT WILL YOU GET?

BAN2401 is given by an intravenous infusion, which is an injection into a vein. You will receive study drug or placebo injections, every 2 weeks for up to 18 months during the main study period. After the completion of the main 18 month study phase, you may receive an invitation to participate in an optional open-label extension study phase. The entire study will take about 4 and a half years to complete.

You have a 50-50 chance of receiving BAN2401.

During the study no one will know what study medication they are on. Each person will receive an infusion regardless of which group the person was assigned to.

WHO CAN TAKE PART?

• Are 50 – 90 years old
• Have a study partner such as a family member, partner, or friend who agrees to accompany you to study visits.

Approximately 1566 individuals will take part in this study.

WHERE IS THIS STUDY TAKING PLACE?

The study will take place at about 200 clinics around the world, including the United States, Canada, Europe, Asia, and Japan.

WHAT HAPPENS DURING THE STUDY?

• You will have an ongoing relationship with a brain health research team.
• You will have a schedule of clinic visits to attend during your participation in the study.
• There is no cost to participate in the Clarity AD clinical study.
• Transportation may be available and you may be reimbursed for your time. You may also have the opportunity to continue in an extension study where you will receive an investigational drug and undergo procedures and assessments at no cost to you.
• Questionnaires to study participants and their study partners about the participant’s health, thinking, memory, and daily activities
• Physical examinations, including blood pressure, heart rate, height, and weight
• Laboratory tests (of your blood and urine)
• Electrocardiograms (ECG)
• Have a study partner such as a family member, partner, or friend who agrees to accompany you to study visits
• Brain MRIs
• Brain PET Scans and/or cerebrospinal fluid collection
• Checking for any side effects or changes to your medications

For more information about this clinical study opportunity and a list of participating research centers, visitClinicalTrials.gov and enter 03887455 or Clarity AD in the “Other Terms” search box.