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news.Eli Lilly and Company has decided to end its contract with the University of California, San Diego (UCSD) for the management of the anti-amyloid treatment in asymptomatic Alzheimer's disease (A4) study.
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A4 is a new clinical trial evaluating 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 trial has been managed by the Alzheimer’s Disease Cooperative Study (ADCS) at UCSD and the funding came from Lilly, the National Institutes of Health (NIH) and multiple philanthropic organizations.
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 (USC).
The company noted that both universities are now engaged in legal proceedings related to this matter. Lilly has been carefully evaluating the best course to ensure the successful continuation and eventual completion of the A4 study.
The company has been publicly stating that its 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.
Lilly Alzheimer’s Platform leader Phyllis Ferrell said: "Lilly continues to be committed to the continuation and completion of this landmark study.
"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."
Following a thorough evaluation of the on-going situation, the company noted that the A4 will continue uninterrupted as it starts discussions with the USC about transitioning management and oversight of the study, while simultaneously workon a transition plan.