EU Consortium to Streamline Alzheimer's Disease Research
By: Lynne Hughes, B.Med.Sci., PhD, PMP | September 21, 2014
Alzheimer’s Disease is becoming a global healthcare crisis. By 2050, the number of people exhibiting dementia worldwide is forecast to rise to 115.4 million, and roughly 43% of AD cases will require levels of care equivalent to that provided by nursing homes. In 2010, caring for dementia patients cost $604 billion worldwide, and the number will continue to grow as populations age.
But a new global initiative, sponsored by the G7 and chaired by UK Prime Minister David Cameron, aims to turn those numbers around. This ground-breaking research program, developed by the European Prevention of Alzheimer's Disease Consortium (EPAD), plans to draw thousands of patients from across the European Union who at risk for early Alzheimer’s, and funnel them into an adaptive trial where multiple biopharmaceutical companies can test and compare drugs in order to streamline the discovery process. The goal of the program is to deliver innovative treatment solutions to market faster and more cost effectively than ever before. Several global biopharmaceutical companies will participate in these trials and Quintiles has been engaged as the CRO of choice for the project at this stage of development.
Getting ahead of AD
One of the most frustrating aspects of AD from a research perspective is that patients don’t seek medical attention until their symptoms are all ready alarmingly evident. This makes it impossible to proactively treat the condition.
One of the primary goals of the EPAD Consortium project is to identify healthy subjects who are at risk for developing AD to participate in these trials. To do that, study leaders plan to engage 24,000 potential study candidates from across the EU by inviting anyone with a history of Alzheimer’s disease in their family and concerns about their own memory to be tested; basically, subjects who feel they are at a high risk for developing this disease in later life This trial registry will feed Phase II studies with patients who demonstrate positive biomarker evidence or other neuro-cognizant traits which may indicate that they will develop early Alzheimer’s disease.
The recruiting opportunity alone for this study has huge implications for the biopharma community. In traditional AD clinical trials, it can take so long to attract and screen patients for the disease that an investigative site may only generate a few candidates per year.
The EPAD model, which will employ digital outreach and recruiting tools, promises to streamline this process and dramatically increase the flow rate of patients while decreasing the site burden of identifying and screening them. Through this centralized digitized model, even with an 80 percent failure rate in the initial registry, the group still expects to have 6,000 subjects identified as being very high risk with a potential sub-set of some 1,500 “trial-ready” subjects for Phase II trials.
Biopharmaceutical companies interested in testing their own Alzheimer’s disease treatments will then be able to purchase an arm (or several) of the study to test their own drugs against a placebo, with new drugs coming in and falling out based on their progress. If a drug shows efficacy, the biopharma company will be able to move it into Phase III studies with high levels of confidence more quickly and at less cost than they would with traditional study designs.
This more efficient model will benefit the biopharma companies eager to bring new drugs to market, and the patients whose lives can be changed by having access to new treatments before this disease takes over. The study will begin in 2015/16 and all of the participating organizations, including Quintiles, are excited about the opportunity to tackle one of our generation’s most pressing global healthcare challenges.