Alzheimer’s Clinical Trial Rules Are Loosened

Alzheimer’s Clinical Trial Rules Are Loosened

July 13th, 2011 // 12:33 pm @


A group of academic and industry experts has convinced the FDA to ease safety restrictions on clinical trials for Alzheimer’s drugs, which were imposed after a 2008 study of a developing med found cases of a brain-swelling condition known as vasogenic edema. That undermined confidence in the safety of drugs focusing on reducing levels of a protein that accumulates in the brains of Alzheimer’s patients.

The new guidelines, which are being published online today in the Alzheimer’s & Dementia journal, will allow some patients who develop brain swelling to stay in clinical trials, a move that may improve the odds for a drug called bapineuzumab, which is being developed by Pfizer and Johnson & Johnson, but caused a dozen cases of brain swelling in a study of 240 people .

“We don’t want to compromise safety, but we also want to make sure as many people as possible can participate in Alzheimer’s clinical trials,” Maria Carrillo, senior director of medical and scientific relations at the Alzheimer’s Assocation tells Reuters. The organization sponsors a Research Roundtable that includes academics as well as various drugmakers, including Pfizer and J&J .

The old guidelines restricted clinical trial patients from having more than two incidents of cerebral microhemmorhages, or tiny leaks of blood in the brain, before they enter a study. And frequent MRI scans were required to check for brain swelling or other problems that might be caused by experimental meds, she explains.

However, Carrillo says the new guidelines acknowledge many patients have had these types of brain events, and excluding those people from trials would make it more difficult to find effective drugs. “We were able to bring together all of the literature involved in the discussion of MRI abnormalities that could occur when you are aging with Alzheimer’s disease and when you are participating in clinical trials with an amyloid-modifying agent,” she says, referring to the beta amyloid protein (you can read the recommendations here).

An accompanying editorial, which was written by Carrillo; Rachel Schindler, a clinical disease expert in Alzheimer’s at Pfizer, and Howard Solomon, a Bristol-Myers Squibb vp and therapeutic area head in global clinical research in neuroscience, maintained that the “process that produced the recommendations and the report is an exemplary case of a recent movement in the fieldof AD toward collaboration and openness of all stakeholders, regardless of affiliation – academic, industry, advocacy,
or government – to advance the process of drug development” in Alzheimer’s.

“Broadening the restrictions would allow a better understanding of the potential risks and benefits of amyloid-lowering treatment,” Schindler tells Reuters. In May, J&J disclosed plans to seek FDA regulatory approval for bapineuzumab in 2012 or 2013, but analysts have said more studies may be needed because of issues with brain swelling.

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