Eli Lilly and Company has notified the University of California, San Diego (UCSD) of its intent to end its contract with the university for the management of the Anti-amyloid Treatment in Asymptomatic Alzheimer's disease (A4) study. The A4 study is a novel clinical trial 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. A4 has been managed by the Alzheimer's Disease Cooperative Study (ADCS) at UCSD. Lilly, the National Institutes of Health (NIH) and multiple philanthropic organizations fund the study.
Dr Paul Aisen, who had been director of ADCS, and many members of the ADCS staff left UCSD this summer to join the University of Southern California. Both universities are now engaged in legal proceedings related to this matter. During this period, Lilly has been carefully evaluating the best course to ensure the successful continuation and eventual completion of the A4 study.
From the outset of this unfortunate dispute, Lilly has publicly stated that the company's objectives are to maintain the safety of the A4 participants, ensure scientific and data integrity for the study and maintain its obligations as the regulatory sponsor.
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. 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.
"Lilly continues to be committed to the continuation and completion of this landmark study," said Phyllis Ferrell, Alzheimer's Platform Leader for Lilly. "We are extremely grateful for the ongoing efforts of the A4 study participants, study investigators and the NIH. We wish to thank UCSD for its work to date and cooperation as the A4 study transitions. Lilly has many ongoing collaborations with researchers at UCSD and within the UC system more broadly, and nothing in our decision concerning the A4 study should be read to reflect any diminished enthusiasm in working with UCSD on these other important projects."
