Alzheimer's Disease & Dementia Studies

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein Eε4 Carriers and Non-Carriers

We are conducting a clinical research study for men and women who have probable Alzheimer's disease. Clinical research is necessary to learn whether investigational drugs work and are safe. The information gained from this study could help future patients who need this type of medical care.

Participants will receive, at no charge, the investigational drug, physical exams, and laboratory services and tests. Throughout the study, participants will be monitored by a medical team including a nurse or study coordinator and a physician. Participants will be randomly assigned to receive one of three doses of the investigational drug or placebo (a treatment with no active ingredient). There is a 60% chance of receiving the investigational drug and a 40% chance of receiving a placebo.

You may be eligible to participate if you:

• Are between 50 to 88 years of age
• Have a diagnosis of probable Alzheimer's disease
• Have a caregiver who is willing to be involved in the study with you

Study participants will be asked to:

• Attend 15 study visits during an 83-week period
• Receive six infusions of the investigational drug every 13 weeks for 65 weeks
• Have blood tests and study-related physical and clinical exams

Alzheimer's Disease Core Center &
Arizona Alzheimer's Disease Consortium

An Alzheimer's Disease Core Center (ADCC) has recently been established in the state of Arizona under the aegis of the National Institute on Aging (NIA) — the Arizona Alzheimer's Disease Consortium.

This effort has as its primary aim, the development of a clinical database that will help to further research in Alzheimer's Disease and other dementing illnesses.  While the ultimate goal is to find treatments and (ultimately) a cure for these diseases, the primary purpose of the ADCC will be to collect data on the clinical manifestations and course of these illnesses, and correlate these data with pathological examination of the brain. This is a multi-center collaborative effort that includes the Sun Health Research Institute, Barrow Neurological Institute, Mayo Clinic Scottsdale, the University of Arizona Health Sciences Center, and the Tucson VA Medical Center. The primary investigator at UMC is Dr. Ahern. The primary investigator at the Tucson VAMC is Dr. Rapcsak.

• Screening of the (potential) subject by a neurologist at one of the participating institutions.  Pertinent laboratory tests will be reviewed.
• If the subject meets entry criteria, they will be invited to enter the ADCC.
• At the first visit, a small amount of blood will be drawn for various genetic studies.
• Upon entry and each year thereafter, they will take pencil-and-paper tests to assess their condition.
• At the time of their demise, the subject will have a brain-only autopsy performed by a neuropathologist at Sun Health Research Institute.


• Although such a requirement may seem drastic to some people, it cannot be emphasized enough that the only way to be absolutely sure of what the patient actually had is through the examination of brain tissue—without this information, a physician can only make an "educated guess" as to what the patient's true diagnosis was—such "guesses" are only correct 85-90% of the time, even in the best clinical centers.
• The brain autopsy is also required of persons participating in the role of "normal controls" (see below).  The reason for this is that even "normal" folks can show changes in their brain as a function of aging and furthermore, may have had an "event" (such as a small stroke) that was clinically-inapparent during their lives.  It is absolutely essential that the researchers have this information, if they are to make valid conclusions regarding what separates a brain affected by a dementia versus a normal brain.
• The NIA is sensitive to the fact that certain groups (e.g., Hispanic, Native American) may have cultural prohibitions against such a procedure—for them, the autopsy requirement can be waived, although we strongly encourage subjects from these groups to consider having the autopsy performed, as it may lead to important discoveries about how diseases such as Alzheimer's may differentially affect people of various races.

We invite interested parties to speak with one of the staff about entry into the ADCC.  This includes not only patients with dementing illnesses, but "normal" people as well.  Being screened, of course, does not guarantee entry in the Core, as multiple factors have to be considered.  But if you are entered into the Core, you can rest assured that you will be making a valuable contribution to research aimed at eliminating these dreaded diseases from the face of the earth.  There are other benefits as well:

• First, your family and descendants will know exactly which disease you suffered from.  This may be of greater and greater importance in the near future, as discoveries derived from the analysis of the human genetic code allow medicine to develop specific cures for specific diseases.  It may also allow your descendants to know what neurological illnesses they are at risk for, which may have great importance if preventative strategies are found for certain diseases.
• Second, all of these procedures (including the autopsy) are performed at no cost to you.
• Third, you may be offered the opportunity to participate in clinical trials being carried out at the member institutions.  Such trials of potential therapies may come from the NIA, National Institutes of Health (NIH), Alzheimer's Disease Cooperative Study (ADCS)—a government-funded, multicenter-consortium of university centers involved in Alzheimer's research, or from the pharmaceutical industry.

If you are interested in participating in the ADCC, we encourage you to contact one of the staff at the Neurology Clinical Research Center.

If you are interested in seeing if someone you know is eligible to participate in any of these studies or if you just want more information, please contact:

Susan Merski, BSN, RN
Research Nurse, Sr.
(520) 626-4296

Lynda Seal, BSN, RN
Research Nurse, Sr.
(520) 626-0868

University of Arizona, Health Science Center, Department of Neurology
1501 N. Campbell Avenue, Room 7329
Tucson, AZ 85724-5023
Fax: 520-626-4903