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(HealthNewsDigest.com) – Researchers at the Stanford University School of Medicine are recruiting participants for a clinical trial of a diagnostic test that may make early detection of Alzheimer’s disease possible.
The multisite study is seeking participants who have been diagnosed with Alzheimer’s, and adults without the disease who expect to approach the end of their lives within the next three years.
Alzheimer’s is a degenerative neurological disease in which degradation of brain tissue causes cognitive problems, such as memory loss and language difficulties, and leads to dementia. The World Health Organization estimates that about 18 million people worldwide have the disorder.
There is currently no one test to conclusively diagnose Alzheimer’s in patients. “Right now the most common way to diagnose Alzheimer’s is to rule out everything else,” said study coordinator Tamara Beale. Patients undergo numerous, costly tests to eliminate other possible causes of cognitive dysfunction, and post-mortem analysis is used to confirm the diagnosis.
Researchers want to find a more straightforward way to detect Alzheimer’s in patients experiencing memory problems in the early stages of the disease. The study will involve giving participants a drug known as florbetaben that acts as a marker for a chemical called beta-amyloid, which can build up and form “plaques” in the brains of Alzheimer’s patients. The researchers will then use a PET scan to detect the amount of plaque buildup in the brain.
Beale emphasized that the study focuses on detecting Alzheimer’s, and does not include any treatment or cure.
The study is funded by Bayer Healthcare, a subsidiary of Bayer AG, and the maker of florbetaben. Rasgon and Beale have no financial or advisory ties to Bayer aside from the study funding. Co-investigator Sanjiv Sam Gambhir, MD, PhD, professor of radiology, is leading another related study funded by Bayer, and has given past talks for Bayer on subjects unrelated to the current study.
The people selected to participate in this phase-3 clinical trial can expect to visit Stanford at least three times. Participants will undergo an initial MRI screening to rule out strokes and other major vascular disease in the brain as causes of dementia, and will receive a copy of the screening report. Participants will also have their blood drawn, and the drug will be injected intravenously. Participants will also undergo a PET scan after receiving the injection. Those participating in the trial will be compensated up to $400 for their time.
Participants will repeat the drug injection and PET scan once every year going forward. The study also includes post-mortem analysis of participants’ brains. A copy of the post-mortem report will be available to participants’ families free of charge.
More information about the clinical trial is available by contacting Beale at (650) 721-2382, or at [email protected].
Information is also available online at http://med.stanford.edu/clinicaltrials/detail.do?studyId=5623 and http://womensneuroscience.stanford.edu/ (click the “New Brain Imaging Study” link at left).
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