Alzheimer's Drug Doesn't Appear To Slow Cognitive Decline

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David Goodhue - AHN Reporter
Boston, MA (AHN) - A promising drug designed to treat Alzheimer's disease was shown not to slow the cognitive decline in people in the late stages of the brain disease, according to a report in the Journal of the American Medical Association.


Dr. Robert C. Green of the Boston University Schools of Medicine, said the drug, tarenflurbil, initially showed promising results in slowing the production of a peptide amino acid that is likely the cause of plaques in the brains of people with Alzheimer's disease.

But he said in a statement that in phase-3 of a recent trial, the drug did not offer better outcomes on a measure of cognitive decline compared to patients receiving a placebo.

Green also said that participants taking tarenflurbil experienced dizziness, upper respiratory tract infections and anemia more than people taking the placebo

Breakthrough in Alzheimer's disease (part 2)

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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.”

Breakthriugh in Alzheimer's disease

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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.

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....read the rest tomorrow

David Holtzman: Attacking Alzheimer's With a New Test for Amyloid Beta

USNews.com

His SILK test quickly reveals whether medication is working to limit the harmful protein amyloid beta
By January W. Payne



Neuroscientist David Holtzman was captivated by Alzheimer's disease as a medical student. Now the 47-year-old associate director of the Alzheimer's Disease Research Center at the Washington University School of Medicine in St. Louis, Holtzman says he realized that Alzheimer's "was going to be one of the biggest problems that we would face, and it was unsolved." Figuring out how the illness begins and how to prevent or slow it has been his goal ever since.

Holtzman's persistence is paying off. Until now, it typically took about two years to determine whether a new Alzheimer's drug was having an effect. But recently, he and colleagues devised a test that rapidly shows whether an experimental medication has a chance of working. "There aren't good ways without doing a long, expensive trial" to determine this, he says. But with the new test, called stable isotope-linked kinetics, or SILK, "we were able to come up with a technique to figure out over a day or two whether a drug is hitting its target in the brain," he says.

SILK reveals whether the.......read all of Attacking Alzheimer's With a New Test for Amyloid Beta

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