Lilly’s decision to end the contract with UCSD came on the same day that a judge for the superior court of California called to preserve the "status quo" and for “all electronic data and computer systems of the Alzheimer's Disease Cooperative Study (ADCS) and any research studies administered by or coordinated through the ADCS, including the Electronic Data Capture system and data” to be returned to UCSD.
The study is currently testing solanezumab in the preclinical stage of Alzheimer's disease in older individuals who have evidence of amyloid in their brains on a PET scan, but do not show symptoms of memory impairment. The study was managed by the ADCS at UCSD and funded by Lilly, the National Institutes of Health (NIH) and other philanthropic organizations.
The legal battle between USC and UCSD was sparked by Dr. Paul Aisen, director of ADCS, who left UCSD in June, along with a team of colleagues, to join USC and continue the study with a higher salary.
UCSD then filed suit, arguing that Aisen and his team took control of the ADCS computer system and database, and precluded UCSD from maintaining its authority over the network.
“The gathering, sorting, storage, analysis and management of data are all essential aspects of the Alzheimer's disease Cooperative Study (ADCS),” the California judge wrote. “In order to maintain the status quo, these functions must be performed to avoid the likelihood of damage to the study and to enable the study to continue to move forward to achieve its stated goals.”
Lilly seems content to continue the study at USC, under the guidance of Aisen.
“After a thorough evaluation of the on-going situation, Lilly has determined that it is in the best interest of the A4 study and its participants to end UCSD's management of the study,” Lilly said in a statement. “The A4 study will continue uninterrupted as the company initiates discussions with the University of Southern California about transitioning management and oversight of the study, while the company will simultaneously work with UCSD on a transition plan.”
But there may be more complications as NIH funding for ADCS remains at UCSD. According to a letter posted on a blog tied to news of the case, Dr. Reisa Sperling, Director, Center for Alzheimer's Research and Treatment, at Harvard Medical School and a project director on the study, apparently wrote to colleagues that she does “not know yet whether the Lilly decision will affect any of the NIH A4 funding. As you are aware, each of your sites currently has two contracts for A4 – one NIH contract and one Lilly contract. I am hopeful that we will be able to work through this transition rapidly, and reissue the Lilly contracts from USC quickly.”