November 02, 2009

Breakthrough in Alzheimer’s disease may lie with new research drug

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Alzheimer’s disease is a neurodegenerative disorder that affects more than 5.3 million families in the United States each year and unleashes a path of emotional and financial heartache for patients and their families.

Alzheimer’s disease is a neurodegenerative disorder that affects more than 5.3 million families in the United States each year and unleashes a path of emotional and financial heartache for patients and their families.

Cleveland Kinney is researching an experimental drug known as bapineuzumab. UAB is participating in national and international Phase III Alzheimer’s clinical trials in which they administer the drug to patients, and there is real hope that bapineuzumab will change the underlying pathology of the disease, ultimately eradicating it from the body.
The disease carries an annual societal price tag of $148 billion, according to the Alzheimer’s Association. It destroys brain cells, which causes memory loss and problems with thinking, and the behavior of patients with the disease can deteriorate to the point that it affects work, lifelong hobbies and social function. Alzheimer’s gets progressively worse, and it is fatal.

But an experimental drug known as bapineuzumab could change all that.

UAB researchers are participating in national and international Phase III Alzheimer’s clinical trials in which they administer the drug to patients every 13 weeks for 18 months, and there is real hope that bapineuzumab will change the underlying pathology of the disease, ultimately eradicating it from the body.

“There has been much effort and money put into this research, and there is real hope for Alzheimer’s patients,” says Cleveland Kinney, M.D., Ph.D., professor of psychiatry and behavioral neurobiology. “What’s so exciting about these new studies and this new drug in particular is the possibility of changing the pathology of the illness. I don’t know if we’ll ever cure it, but I think it will be managed by a cocktail of medicines and patients will be able to live a normal life.”

Bapineuzumab appears to undermine the grip the disease-causing proteins has on the brain, and that is the reason there is promise in the drug’s efficacy.

Current Alzheimer’s medications, including Aricept, Exelon and Razadyne — the three most popular cholinesterase inhibitors used to treat patients — act as managers of the disease. They maximize the remaining brain activity and slow the disease.

Bapineuzumab uses an antibody not commonly found in the patient’s blood to treat Alzheimer’s. It is designed to bind to a particular protein called beta amyloid protein, which accumulates in the brain and forms plaques related to the progression of the disease. It is hoped that bapineuzumab will attach to the beta amyloid protein in the brain and help the body remove it. Researchers also believe the drug will prevent the build up of beta amyloid protein.

“It’s particularly fascinating that as the study progresses and the plaques are dissolved, the brain shrinks because it’s getting rid of space-occupying lesions,” Kinney says. “But the patients theoretically do better over time, which means they are re-establishing connections in the brain they had lost because the plaques were there.

“If you get rid of the plaques the patients do better; the brain shrinks and the connections are re-made,” he says. “If that’s the case, that means the brain is far more plastic than anyone ever thought possible. That’s what we think is going to happen.”

The studies look at two different patient populations — those carrying what is known as apolipoprotein ε4 gene (APO ε4) alleles and those who do not. APOE contains the instructions needed to make a protein that helps carry cholesterol in the bloodstream and comes in several different forms. Three of those alleles occur more frequently than others. Dozens of studies have confirmed that the allele identified as APOE ε4 increases the risk of developing Alzheimer’s, but the way that happens is not yet understood.

Administered through infusions
Patients in the trials undergo an infusion of bapineuzumab every 13 weeks in addition to several MRI scans and neuropsychological testing. More than 100 sites in the United States are participating in the randomized study funded by Elan, but UAB is the only participating site in Alabama. Numerous sites around the world are participating in an identical study funded by Wyeth. UAB is enrolling participants in both studies.

The studies are double-blind and placebo-controlled. Sixty percent of patients enrolled in the studies will receive the drug, and 40 percent will not. Participants will be given the opportunity to receive the study drug in an extension study after the 18-month study has been completed.

UAB is in the top 25 percent in the country for enrolling participants in the studies, and more are being sought. Potential participants can call the Office of Psychiatric Research at 934-2484 to be screened. Patients currently taking Aricept, Exelon, Razadyne or other Alzheimer’s drugs will continue to take their existing medications in addition to the trial medication.

Those who are eligible to participate in the study must be between ages 50 and 88, have a diagnosis of probable Alzheimer’s disease, and have a caregiver who is willing to be involved in the study.

“Something will come out in the not too distant future that I think will be pretty miraculous,” Kinney says. “If it weren’t promising, we wouldn’t be participating in the study.”

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