Guidelines established for use in clinical trials of Alzheimer’s blood test

October 2, 2014

Researchers have moved a step closer to making a simple blood test to detect early Alzheimer’s disease available for screening older adults.

The first standardized guidelines for the collection of blood to test for early Alzheimer’s disease have been established by an international working group led by UNT Health Science Center.

These guidelines are needed before the blood test can be put into the hands of primary care physicians, said Sid O’Bryant, PhD, Interim Director of the Institute of Aging and Alzheimer’s Disease Research.

The highly rigid guidelines will be used in research for blood-based biomarkers of Alzheimer’s disease and will ensure every lab is following the same protocol when collecting blood, said Dr. O’Bryant, a member of the group and lead author of the paper published in Alzheimer’s & Dementia outlining the standards.

“You can create a blood test in the lab, but if you don’t have a systemized way for collecting the blood, the test will never go into practice,” he said. “You’ll have one lab doing it one way and another lab doing something different.”

Dr. O’Bryant worked with representatives from across the United States, Australia, Germany, England and other countries to create the standards. Everything from the type of needle used to draw blood to the length of the storage time is specified in the guidelines.

Just as with blood tests for other diseases, such as diabetes, protocols must be established to make sure every lab performs the test exactly the same. Such guidelines are needed before FDA approval can be sought to use the test in a clinical setting.

“With these guidelines, the next step is to do a clinical trial involving patients,” Dr. O’Bryant said. “That’s never been done before.”

Diana Cervantes. Assistant Professor Biostatistics & Epidemiology
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