A full work-up for Alzheimer’s disease

LAS VEGAS—Moving a step closer to increasing opportunitiesto diagnose Alzheimer's disease before memory loss occurs, the ClevelandClinic's Lou Ruvo Center for Brain Health has been chosen by Paris-basedExonhit SA to conduct the first U.S. pilot clinical trial for AclarusDx, ablood-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 patientsbeing 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'sParis facility for AclarusDx test analysis.

Dr. Kate Zhong, senior director of clinical researchdevelopment at the Ruvo Center, says being able to diagnose Alzheimer's diseaseearly is vital as more baby boomers become senior citizens and people livelonger than expected.

About half of Americans over the age of 85 will getAlzheimer's disease, she says. Also, an estimated 5.4 million Americans haveAlzheimer's disease, with that number expected to increase to 16 million by2050. If trends continue, Alzheimer's will cost taxpayer-supported Medicare andMedicaid $20 trillion by 2050, according to an Alzheimer's Study Group reportreleased last year.

If the trials are successful and the specific blood test candiagnose Alzheimer's, this will provide a quick, less invasive and affordablemeans to diagnose Alzheimer's at an early stage, Zhong says.

Currently, an Alzheimer's diagnosis is based on psychometrictests and behavior evaluations, as well as brain imaging at a stage of thedementia where the onset of the disease has already started, reports Exonhit.Early, accurate and reliable diagnostic tools are essential to improve patientmanagement and therapeutic treatments. The use of AclarusDx could helpaccelerate the full diagnostic workup.

The Cleveland Clinic Alzheimer's trial consortium "is one of the leading Alzheimer'strial 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 ClinicSOP."

Individuals chosen for the study will be "patients who havememory complaints, patients who visit their primary care provider for adiagnostic work up," she says. "There is no age limitation; it could be anyonewho 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 havingAlzheimer's compared to those who don't."

Two successful trials on patients in France using theAclarusDx test have proven successful, according to Exonhit.

"If successful, the findings from this trial will aidphysicians for early detection and early treatment in this population," Zhongsays. "The goal is to obtain FDA approval on the utilization of AclarusDx asthe diagnostic assay for Alzheimer's disease."

Dr. Loïc Maurel, president of Exonhit's management boardstated, "Knowing that 5.4 million Americans are living with Alzheimer's andthat the disease costs $183 billion per year, significant efforts have to bemade to identify Alzheimer's at its very early stages to improve the managementof the disease. Our ultimate goal is to define the clinical utility ofAclarusDx to provide primary care physicians with a diagnostic tool that willhelp them identify patients at high risk of having Alzheimer's and to prescribea complete diagnostic workup."

Exonhit extends strategic collaboration with Allergan

PARIS—ExonHit SA also announced in November the extension ofits existing drug discovery collaboration with Allergan Sales LLC. Thecollaboration was initiated in December 2002 and extended several times. It nowis further extended until December 2013.

The collaboration will continue to focus on theidentification, development and commercialization of drugs for the treatment ofneurodegenerative diseases, pain and ophthalmology.

"We are very pleased that our longstanding strategiccollaboration with Allergan will continue until the end of 2013. Thecollaboration has created significant value for both organizations, and we areoptimistic that it will continue to build upon recent successes and advanceadditional existing preclinical programs into clinical development," said LoïcMaurel, CEO of Exonhit, in a statement.

Detailed financial terms were not disclosed.