Safety First: New Clinical Trial Guidelines

Alzheimer’s disease is the only disease in the top 10 causes of death without effective treatment or a cure. This can be shocking news for a newly diagnosed person. Not long after my 49-year-old husband was diagnosed with dementia of the Alzheimer’s type, we heard about a Phase III clinical trial for a new Alzheimer’s drug. After agonizing about safety versus the possibility of a drug that might stave off the disease, we enrolled Jim in the study.

We saw immediate advantages: free evaluations by the neurologist in charge of the study group, ongoing cognitive testing and, most important to us, the Alzheimer’s study drug. It seemed like a win-win situation, until three weeks later nausea, diarrhea and general stomach distress set in. Later, we learned the study was terminated and the drug wasn’t approved.

Now, the Alzheimer’s Association Research Roundtable working group and the U.S. Food and Drug Administration (FDA) have announced new safety recommendations for Phase I and II amyloid-lowering drug trials. Original FDA guidelines would have stalled the research process by eliminating participants with certain age-related brain changes. The new guidelines are a compromise to allow more pre-existing brain conditions than the FDA originally allowed while closely monitoring any changes.

Thankfully, Jim’s side effects were minor, but everyone who enters a drug trial takes a chance on unexpected results. Families understand the urgency for effective treatment, but want safety to be a priority.

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