CASTLE ROCK, Colo. — Monday's announcement of a newly approved Alzheimer's drug has renewed optimism for Sam Van Why, whose wife is battling Alzheimer's disease.
Sam Van Why is patient and loving with his wife, Donna Van Why.
When she's upset, he takes her hand. When she can't find the right words to say, he quietly suggests a phrase.
The Castle Rock couple has been married for nearly thirty years, and, like most marriages, they've seen the ups and downs life can bring. Now, they're facing their biggest challenge yet.
"I've seen some digression, particularly this past year," Sam Van Why said. "These past 13 months have really been hard.""
Donna Van Why is battling Alzheimer's disease. She recognizes the changes in herself, too.
"It's been up and down," she said.
Sam Van Why's brother and mother also had Alzheimer's disease and passed away from complications related to it.
"I thought I would be the one that Donna would be caring for," he said. "It's depressing for me to see the changes with Donna, particularly after going through similar with my mom and then my brother."
The FDA accelerated approval for an Alzheimer's drug, Biogen's aducanumab, has brought renewed hope that things can be different for Donna.
"That's what we have as our goal," he said.
The accelerated approval means the pharmaceutical company will have to conduct a post-approval clinical trial, also known as Phase 4 research. If the drug's Phase 4 research doesn't verify the drug's benefit, it could be removed from the market.
"The CU Alzheimer's Center will be a participant in that Phase 4 study going forward," said Dr. Victoria Pelak, professor of Neurology and Ophthalmology at the University of Colorado Alzheimer’s and Cognition Center.
"It is a drug to remove the Alzheimer's proteins that abnormally build up in the brain and then develop Alzheimer's disease," Pelak said.
Pelak believes the Alzheimer's Association has put good context around expectations.
"Cautiously optimistic is really a good way to put it, because we know this drug is not for everyone; it's only for a specific population of patients that have mild symptoms," she said.
Pelak said some trials have shown the drug's effects may not be noticeable, one of the reason's the FDA's decision for accelerated approval has been met with controversy.
In November, an FDA advisory panel voted against approval saying aducanumab failed to meet the usual scientific standards.
"The clinical benefits, so the benefits that a person and their family might notice, are very minimal. The decline is slower, and sometimes that's very hard to recognize on an individual basis." Pelak said.
"Right now we're still waiting for Biogen and the FDA to give the prescribing material so we understand how it's going to be prescribed and exactly who is eligible to receive the medication. The same with the study, we have to wait for the company to provide to us the exact mechanisms for enrolling and who is going to be eligible - that's upcoming probably within the next few moths," Pelak said.
She added CUACC has expressed hope to enroll one person a month in the Phase 4 study.
"I hope Donna will qualify. I think that would be wonderful," Sam Van Why said. "We know it's not a cure, its simply adding more time. Regardless of whether or not Donna will qualify for it, we're still excited that more people will have the opportunity."
A link to Sam Van Why's fundraising efforts for a cure can be found here.