Biogen’s aducanumab treatment for Alzheimer’s dementia has faced a lot of controversy in recent months, with patients and families pushing for FDA approval while the FDA’s own expert panel advised against it.
Finally, the drug was approved earlier this week, and the FDA explained its decision by highlighting the reduction of the amyloid protein that is a key component of Alzheimer’s disease progression.
Across both of Biogen’s Phase III Trials, PET scans revealed a significant reduction in the proteins, though a higher dosage of the drug correlated with less cognitive decline in only one of the trials. The biomarker of reduced amyloid accumulation is present in some other Alzheimer’s treatment trials, but the Biogen drug also saw a reduction in Tau (another protein related to the progression of Alzheimer’s.)
The FDA approval of the drug despite controversy follows two decades of research into using imaging biomarkers in Alzheimer’s studies. This time has also seen the development of the Alzheimer’s Disease Neuroimaging Initiative )ADNI) involving academics, industry leaders, and over 1,000 volunteers contributing data and samples in the journey toward better diagnostics and disease understanding.
One goal of these efforts is to eventually be able to identify genetic markers for those at risk of developing Alzheimer’s before the disease can take hold, enabling researchers to begin testing drugs that might hopefully prevent symptom onset altogether.
This level of collaboration demonstrates on a large scale how much patients and their families depend on projects like ADNI and other volunteer clinical research in order to better understand and treat diseases. As Ken Marek of Stats News describes it: “We can pull together the world’s most elite teams of scientists, raise hundreds of millions in funding, and establish a global scientific infrastructure, but without study participants it’s all for naught.”
Want to learn more?
In addition to reporting clinical trial news and stories from within the patient community, we operate Citrus, a fully integrated recruitment and retention software. Citrus fits any clinical trial and simplifies the implementation of patient engagement in your clinical trial. Whether you are already working with CTMS systems or not, Citrus is the perfect add-on to make patient interaction effective.
Since 2015, our team has been hard at work raising awareness of clinical trials across the globe. A Forbes ‘30 Under 30’ company and a graduate of the renowned Techstar program in New York, Citruslabs is at the forefront of patient recruitment and retention technologies. With over 3 million patients now recorded on our databases, our patient recruitment dashboard is fast becoming the most efficient method of trial recruitment.
Now a #1 health app in 17 countries, our Mindmate app is helping to revolutionize the way we think about healthcare. Mindmate “[takes] senior care into the digital age” (Forbes, 2018) by providing people with the cognitive decline the essential tools to help them rebuild and maintain strong mental health. Trusted by millions of users, our health community continues to grow as the content available expands to the needs of individuals today.
With more than 200 research sites now using the Citrus platform to screen thousands of patients every month, researchers are now well on their way to finding new treatments for hundreds of different health conditions - something that just would not be possible without a technological solution. Make sure that your clinical trial is in the lucky 12% and turn that luck into guaranteed results with Citrus.