ST. LOUIS—Washington University School of Medicine in St.Louis has announced a collaborative Alzheimer's trial that will combineacademic institutions and industry members to evaluate several drugs todetermine if they are capable of preventing Alzheimer's disease. The trial,which will aim at determining if the drugs can improve Alzheimer's biomarkersand prevent cognitive function loss, is set to begin early next year.
SOURCE: Washington University School of Medicine St. Louis press release
The Dominantly Inherited Alzheimer's Network Trials Unit(DIAN TU) at Washington University School of Medicine in St. Louis will conductthe trial.
"This trial is the result of a groundbreaking collaborationbetween academic institutions, pharmaceutical companies and patient advocacygroups, with key support from regulatory groups," said principal investigatorRandall Bateman, M.D., the Charles F. and Joanne Knight Distinguished Professorin Neurology at Washington University School of Medicine in St. Louis. "We areexcited that this diverse portfolio of drugs and approaches will accelerate thediscovery of an effective treatment for Alzheimer's."
The undertaking will focus on three investigational drugs tobegin with, chosen from more than a dozen nominations that were submitted bythe DIAN Pharma Consortium. Each drug counters the effects of amyloid beta, theprimary component of cerebral plaque in Alzheimer's patients, and hassuccessfully completed earlier clinical trials to evaluate the drugs forsafety, effectiveness and engagement of targets in patients.
Gantenerumab from Roche, an antibody that binds to all formsof aggregated amyloid beta and aids in their removal from the brain, is one ofthe drugs selected. The candidate is currently undergoing an internationalphase III trial, SCarlet RoAD, which began in 2010, to determine its ability tostop Alzheimer's prior to the onset of dementia. Another candidate issolanezumab from Eli Lilly and Co., a monoclonal antibody that binds to solubleforms of amyloid beta once they are produced, allowing the peptide to beremoved before it aggregates and forms plaques. A beta-secretase (BACE)inhibitor from Lilly, which is believed to reduce the amount of amyloid betaprotein produced, has also been selected to potentially be included in thetrial.
"Roche is honored that gantenerumab was selected by DIAN tobe a part of this groundbreaking Alzheimer's disease study," Luca Santarelli,head of Roche Neurosciences, said in a statement. "This clinical test supportsRoche's commitment to provide earlier treatment options to those at risk forthis devastating disease."
"We are pleased that Lilly was chosen to contributesolanezumab, and potentially our beta-secretase inhibitor, for use in thispioneering Alzheimer's disease study," Jan Lundberg, Ph.D., executive vicepresident, science and technology, and president, Lilly Research Laboratories,said in a press release. "We look forward to collaborating with the DIAN TUinvestigators, along with the other public and private partners, to betterunderstand if early treatment with these investigational medicines caninfluence this terrible disease."
The treatments have been made available by Roche and Lillyat no cost, and the companies have also agreed to provide grants for each drugto help fund the trial. Additional funding will come from a $4.2 million grantfrom the Alzheimer's Association. The investigators leading the trials haveapplied for additional support through the National Institutes of Health, andthe grant application is currently being reviewed by the National Institute onAging.
The trial will consist of 160 people with inheritedmutations that generally guarantee the development of Alzheimer's somewhere intheir 30s to their 50s, as well as 80 DIAN participants who lack theAlzheimer's mutations. All subjects will be within 10 to 15 years of theforecasted age when symptoms such as dementia and cognitive decline areexpected to present, a point at which DIAN studies have shown those withAlzheimer's mutations are most likely to present biological indicators markingthe beginning of the disease in the brain. The researchers will monitor thesemakers to determine if the treatments can slow or stop Alzheimer's. the firstpart of the trial is slated for two years, with plans for it to be expanded andextended if any of the drugs are effective in slowing or stopping Alzheimer'sindicators.
"This is a very exciting moment in Alzheimer's diseaseresearch, and it gives me renewed hope for a future without Alzheimer's," BrentWhitney, DIAN participant, said in a press release. "I hope my grandchildrensomeday learn of this condition in history books, like I learned about polio."
SOURCE: Washington University School of Medicine St. Louis press release
