Clinical Trial 14618

Toms River, NJ 08755

Study Summary:

Making memories is easy. Making them last is the hard part.
Current medications for Alzheimer’s disease focus on treating the symptoms, but they do not work to stop the disease from developing or from getting worse over time. The 3133K1-3000 Alzheimer’s study is testing an investigational medication designed to slow the progression of the disease.

About the Study
The main purpose of the 3133K1-3000 study is to evaluate an investigational medication called bapineuzumab to see if it may safely and effectively slow the progression of Alzheimer’s disease. To do this, researchers will evaluate and monitor study participants’ memory and other measures of brain function, as well as their ability to perform day-to-day activities.

About the Study Drug
Recent advances in Alzheimer’s research suggest that a protein called beta-amyloid builds up in the brain and forms plaque. These plaques damage and destroy nerve cells and are thought to be related to the development of Alzheimer’s disease. Bapineuzumab is designed to target the beta-amyloid protein in the brain and help the body remove it. Removing the protein may slow down the buildup of plaque and in turn slow down the progression of Alzheimer’s disease.

Who can participate in the study?
You (or someone you know) may be eligible to participate if you:

  • Are 50 to 88 years of age
  • Have been diagnosed with mild to moderate Alzheimer’s disease
  • Are able to have an MRI scan
  • Have a caregiver who can come to all clinic visits
There are other eligibility requirements that the study doctor or staff will review with you.

What will the caregiver be asked to do?
The caregiver for this study will be asked to:
  • Attend all study visits with the participant and stay until the visit is over
  • Visit the participant approximately five times per week
  • Answer questions and provide information about the participant’s activities, behavior, and how he or she is doing
If for any reason the caregiver cannot continue to assist with the study, a new caregiver may take over the role.

What will happen during the study?
Participation will last for approximately 20 months. During this time, participants and caregivers will be required to visit the study clinic approximately 15 times.

Participants will have to:
  • Come to the clinic with a caregiver
  • Receive intravenous (IV) infusions
  • Stay for up to 4 hours
  • Answer questions
  • Have exams and procedures
Throughout the study, participants will be monitored by a medical team, including a nurse or study coordinator and the study doctor.

Participants may or may not benefit from being in the study, but what we learn from the study may help improve treatment options for patients with Alzheimer’s disease in the future. Study participation is voluntary, and participants can leave the study at any time without it affecting the medical care they receive from their family doctor.

Where is the study taking place?
Sites may be added during the study, so please check back often if there are currently no sites located near you that you are willing to travel to at this time.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.