Eli Lilly has notified the University of California, San Diego (UCSD) of its intent to end its contract for the university’s 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 NIH and multiple philanthropic organizations fund the study.
Dr. Paul Aisen, who had been director of ADCS, and many ADCS staff members left UCSD this summer to join the University of Southern California. Both universities now are engaged in legal proceedings related to this matter.
From the outset of the dispute, Eli 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.
The A4 study will continue uninterrupted as Eli Lilly 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.
Solanezumab is Eli Lilly’s phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer’s disease. Solanezumab binds to soluble monomeric forms of amyloid-beta after it is produced, allowing it to be cleared before it clumps together to form beta-amyloid plaques.