Arriving home from the Bionic Brigade meeting (AKA Denver’s DBS support group), I had three emails with breaking news for the Parkinson’s community: the imaging technique, DaTscan. I’ve encountered so many folks who’ve been bounced from doctor to doctor for years before being diagnosed with Parkinson’s Disease. Finally, an objective test has been developed, which was approved by the FDA today.
The following is from the Michael J. Fox Foundation at: http://www.michaeljfox.org/newsEvents_parkinsonsInTheNews_article.cfm?ID=692January 14, 2011
Michael J. Fox Foundation Applauds FDA Approval of DaTscan, Heralds Benefits for Parkinson’s Disease Drug Development and Patient Care
Today’s FDA approval of DaTscan, an imaging technique that captures detailed images of the living brain, including areas affected by Parkinson’s disease, stands to benefit both drug development and patient care for Parkinson’s. DaTscan is the first FDA-approved diagnostic imaging agent to aid in the assessment of degenerative movement disorders such as Parkinson’s disease. In keeping with The Michael J. Fox Foundation’s commitment to mobilize new technologies quickly in its urgent pursuit of a cure, DaTscan is already in use at 14 U.S. medical centers as part of the Parkinson’s Progression Markers Initiative (PPMI), the Foundation’s landmark clinical study seeking biomarkers of Parkinson’s disease.
“For the first time, an objective test can help confirm a clinical diagnosis of Parkinson’s disease,” said Katie Hood, CEO of The Michael J. Fox Foundation for Parkinson’s Research. “DaTscan represents a major step forward in enabling timely initiation of appropriate treatment and improved disease management, which contribute to greater quality of life and better long-term outcomes.”
Parkinson’s disease is diagnosed through clinical examinations, but especially early in disease this may be inconclusive and can result in misdiagnosis. DaTscan offers an objective tool to help with early and accurate detection of PD.
“Until now, it has been impossible to confirm that patients enrolling in clinical studies of Parkinson’s disease actually had the disease,” said Todd Sherer, PhD, Chief Program Officer, The Michael J. Fox Foundation. “Having more homogeneous patient populations in clinical trials will contribute to clearer trial outcomes and help speed progress toward improved treatments and a cure.”
“Like many Parkinson’s clinical studies, PPMI requires the participation of PD patients at the earliest stages of symptoms when diagnosis may still be uncertain,” said Ken Marek, MD, principal investigator of PPMI. “DaTscan is critical to ensuring the accuracy of diagnosis of both Parkinson’s patients and control participants entering PPMI and is therefore crucial to the study’s success.”
GE Healthcare, manufacturer of the imaging agent used in DaTscan, is one of seven industry partners supporting PPMI. GE is providing the DaTscan imaging agent at no cost to PPMI clinical sites in the United States and Europe.
DaTscan has been approved in Europe for over 10 years. More than 300,000 people have undergone DaTscan imaging internationally, and the procedure has not posed significant safety issues.
Comments