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A full work-up for Alzheimer’s disease
LAS VEGAS—Moving a step closer to increasing opportunities to diagnose Alzheimer's disease before memory loss occurs, the Cleveland Clinic's Lou Ruvo Center for Brain Health has been chosen by Paris-based Exonhit SA to conduct the first U.S. pilot clinical trial for AclarusDx, a blood-based investigational diagnostic test.
Patients for this study will be recruited at three sites: the Ruvo Center in Las Vegas; the Cleveland Clinic main campus in Cleveland, Ohio; and Lakewood Hospital in Lakewood, Ohio. A total of 160 new patients being seen by physicians for memory impairment will be enrolled in the trial. The first patient was to be chosen last month.
The blood samples will be sent to biotech company Exonhit's Paris facility for AclarusDx test analysis.
Dr. Kate Zhong, senior director of clinical research development at the Ruvo Center, says being able to diagnose Alzheimer's disease early is vital as more baby boomers become senior citizens and people live longer than expected.
About half of Americans over the age of 85 will get Alzheimer's disease, she says. Also, an estimated 5.4 million Americans have Alzheimer's disease, with that number expected to increase to 16 million by 2050. If trends continue, Alzheimer's will cost taxpayer-supported Medicare and Medicaid $20 trillion by 2050, according to an Alzheimer's Study Group report released last year.
If the trials are successful and the specific blood test can diagnose Alzheimer's, this will provide a quick, less invasive and affordable means to diagnose Alzheimer's at an early stage, Zhong says.
Currently, an Alzheimer's diagnosis is based on psychometric tests and behavior evaluations, as well as brain imaging at a stage of the dementia where the onset of the disease has already started, reports Exonhit. Early, accurate and reliable diagnostic tools are essential to improve patient management and therapeutic treatments. The use of AclarusDx could help accelerate the full diagnostic workup.
The Cleveland Clinic Alzheimer's trial consortium "is one of the leading Alzheimer's trial organizations," Zhong tells ddn. "We are ideally positioned to provide the large volume of trials participants, rapid start-up, with one IRB, one contract, one budget and Cleveland Clinic SOP."
Individuals chosen for the study will be "patients who have memory complaints, patients who visit their primary care provider for a diagnostic work up," she says. "There is no age limitation; it could be anyone who has a perceived memory problem.
"Alzheimer's does have a genetic component," Zhong adds. "Those who carry APOE 4 genes have a much higher likelihood of having Alzheimer's compared to those who don't."
Two successful trials on patients in France using the AclarusDx test have proven successful, according to Exonhit.
"If successful, the findings from this trial will aid physicians for early detection and early treatment in this population," Zhong says. "The goal is to obtain FDA approval on the utilization of AclarusDx as the diagnostic assay for Alzheimer's disease."
Dr. Loïc Maurel, president of Exonhit's management board stated, "Knowing that 5.4 million Americans are living with Alzheimer's and that the disease costs $183 billion per year, significant efforts have to be made to identify Alzheimer's at its very early stages to improve the management of the disease. Our ultimate goal is to define the clinical utility of AclarusDx to provide primary care physicians with a diagnostic tool that will help them identify patients at high risk of having Alzheimer's and to prescribe a complete diagnostic workup."
Exonhit extends strategic collaboration with Allergan
PARIS—ExonHit SA also announced in November the extension of its existing drug discovery collaboration with Allergan Sales LLC. The collaboration was initiated in December 2002 and extended several times. It now is further extended until December 2013.
The collaboration will continue to focus on the identification, development and commercialization of drugs for the treatment of neurodegenerative diseases, pain and ophthalmology.
"We are very pleased that our longstanding strategic collaboration with Allergan will continue until the end of 2013. The collaboration has created significant value for both organizations, and we are optimistic that it will continue to build upon recent successes and advance additional existing preclinical programs into clinical development," said Loïc Maurel, CEO of Exonhit, in a statement.
Detailed financial terms were not disclosed.