For the first time in more than a decade, a new treatment to improve brain function for Alzheimer’s disease has been submitted to the Food and Drug Administration (FDA) for review.
This was after the drug trial was stopped and then a second look revealed some promising results.
The Waterhouse family has seen the impact of Alzheimer’s firsthand.
Gina and Steve Waterhouse have been a team most of their lives. They’ve been married for 43 years and ran several businesses together. Then in 2016, things started to change. Gina didn’t notice anything but employees at the family's businesses did.
“I wasn't remembering some of the stuff I was supposed to be doing,” said Gina.
Gina was diagnosed with early Alzheimer's disease that year.
“They said, 'well you can come back in a year. We will check and see how you're doing, or we have a drug trial if you're interested,'” said Gina.
Gina and Steve spent the next two and a half years at the Mayo Clinic, where Gina eventually got high doses of the drug aducanumab.
Steve started to notice Gina was remembering more things and reported it back to doctors.
“He just smiled and said, 'let me tell you what we're seeing. We're seeing cognitive improvement. And it’s the first time in my career.' These doctors said in their career that we've ever seen it,” said Steve.
“He was so excited,” said Gina.
Then in 2019, the drug trial suddenly ended. Gina says she felt like she’s gone downhill a little since it did.
Rebecca Edelmeyer, PhD, with the Alzheimer’s Association, says the trial stopped early based on a futility analysis.
“It was a statistical analysis that was done by the Biogen team, predicting that the trial would not actually be successful,” said Edelmeyer.
Edelmeyer says then upon a second look at the trial data, they found that those people on the highest dose of the drug were seeing improvement in their brain function. She called it a very important moment for the Alzheimer’s research community.
Now, the government will determine whether or not the drug is safe and effective enough to use.
Steve mentioned there were some possible side effects like bleeding of the brain, but Gina did not experience any.
Meanwhile, Gina can no longer take the drug. She and Steve have decided to retire.
“We just decided tomorrow has to come today and we're having a great time. We're loving life,” said Gina.