A clinical trial participant from #GAPNet site, JEM Research, talks with her husband about their experience in the Aducanumab trial, which is pending approval by the US Food and Drug Administration by March 2021.
There are currently more than five million Americans living with Alzheimer’s disease… and despite ongoing research, there has been no new approved drug for Alzheimer’s since 2003. Now, a new drug that is showing mixed results in trials is still giving Alzheimer’s patients a lot of hope.
76-year-old Jane Burnham loves to keep her mind sharp. She also likes to do the same for her husband Jim.
“We’ve been married for over 50 years, how many?” Jane asks Jim.
“54,” Jim replies.
“Okay,” Jane chuckles.
But you would never have known that she was diagnosed with early-stage Alzheimer’s more than four years ago.
“There were instances that we kind of thought were senior moments and they were happening way too often,” Jim recalled.
Jane enrolled in a trial for the Alzheimer’s drug aducanumab. Participants were given the drug once a month as an IV infusion. It’s designed to attack amyloid protein, a biomarker of Alzheimer’s.
“Used aducanumab as a monoclonal antibody to attach to amyloid protein in the brain and remove it,” explained Mark Goldstein, MD, CPI, Principal Investigator at JEM Research Institute.
Results from one of two clinical trials showed patients who got higher doses of the drug showed 22% less clinical decline than the placebo group. But the other trial showed no positive results. Now there is a current ongoing trial for aducanumab to provide more data.
“There’s no placebo arm, so everybody will get the drug, and in addition, everybody is going to get the high dose of the drug,” clarified Dr. Goldstein.
Jane took part in the first trial and is now doing this ongoing trial. The mixed results haven’t changed the Burnhams’ minds about the drug.
“I think that Jane’s progression is very slow and the differences from several years ago are probably minimal and that, of course, I relate to the drug,” Jim shared.
In early November, an FDA panel voted not to endorse the Alzheimer’s drug stating there is not enough evidence to show its effectiveness. However, the drug is still up for official FDA approval in March 2021. The FDA can still approve aducanumab even if the panel does not endorse it.
Originally posted by NBCDFW on December 30, 2020.