The Innovative Medicines Initiative (IMI) together with the Global Alzheimer’s Platform (GAP) recently announced the signing of a Memorandum of Understanding (MOU) agreement based on the common goal of accelerating the search for an Alzheimer’s disease therapy through the creation of a global, standing, trial-ready platform for Alzheimer’s drug development. The announcement was made at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Nice, France.
“Alzheimer’s disease is a global challenge that requires a global solution, and it is in this spirit that the IMI and GAP will collaborate and align their research. The Memorandum of Understanding is the evidence for our genuine interest in working together to create an international clinical trials platform,” said the IMI Acting Executive Director Dr. Irene Norstedt in a news release. “Everyone working on Alzheimer’s disease needs to pull together if we want to deliver results that will help us to end the suffering caused by this terrible disease.”
The aims of this global collaboration between the European IMI and the American GAP are to recruit patients for clinical trial studies, to generate a high-performing clinical trial system and to develop a standardized protocol to rapidly analyze new potential drugs and advance the development of the ones that show promising therapeutic results. The fact that currently there is no organized pool of individuals known to have Alzheimer’s or at risk of developing the disease who can be readily contacted and are willing to enroll in clinical trial studies is seen as an obstacle that delays drug development. This collaboration hopes to overcome this difficulty by creating a global, standing, well-characterized trial-ready platform to effectively deliver proof of concepts, confirmatory trials and reduce drug testing time by at least two years, enabling a faster delivery of effective therapies.
“This agreement represents an important commitment from major initiatives in Europe and the United States to expand and improve our capacity to conduct trials in Alzheimer’s in order to bring innovative medicines to patients faster,” explained George Vradenburg, chairman and co-founder of USAgainstAlzheimer’s. “Through our collaborative efforts here in the U.S., organized through GAP, and with these consortia in Europe, we believe we can begin to design a truly global clinical trial system of speed, power, and efficiency. No one company or one government can do this alone. We must have a global commitment and it must come from government, industry, and academia and be driven by the passion and urgency of the patient community.”
This partnership is expected to lead to faster and less expensive clinical trials for Alzheimer’s and dementia, saving individuals and pharmaceutical industries time and money.
“This collaboration has the potential to be a game changer for Alzheimer’s drug development,” noted Dr. Janet Woodcock at the U.S. Food and Drug Administration. “A global trial-ready platform will increase our prospects of finding important biomarkers, or discovering effective treatments for Alzheimer’s. If we don’t do this, we may be facing decades of uncoordinated, one-off efforts that fail to enhance our ability to accelerate learning and human testing and really move the field forward.”
Alzheimer’s disease is a neurodegenerative disorder where individuals initially experience memory loss and confusion that gradually leads to behavior and personality changes, a decline in cognitive abilities, and ultimately to severe loss of mental function. There is currently no cure and it is estimated that Alzheimer’s disease and dementia are responsible for more than 500,000 deaths in the United States and more than 44 million worldwide every year. By age 85, one in every three individuals will have Alzheimer’s disease.