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.”
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