FDA approves innovative Alzheimer’s drug tested at UAB

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Doctors in UAB's clinical trial had to prove that their drug was effective in removing amyloid protein from the brain. Photo courtesy of Alzheimer's Association of Alabama.
Doctors in UAB’s clinical trials had to prove that their drug was effective in removing chemical abnormalities from the brain. Photo courtesy of Alzheimer’s Association of Alabama.

The first FDA-approved drug to slow the decline of Alzheimer’s was approved today, and the University of Alabama at Birmingham has been involved in clinical trials of the drug for five years. We talked to Alzheimer’s researchers and advocates at UAB to learn more.

A critical step forward

Amyloid is the peptide that clumps into sticky brain plaques over the course of Alzheimer's disease. Photo courtesy of Alzheimer's Association of Alabama.
Amyloid is the peptide that clumps into sticky brain plaques over the course of Alzheimer’s disease. Photo courtesy of Alzheimer’s Association of Alabama.

Today, the FDA approved aducanumab, which will be marketed under the name Aduhelm. The drug slows the decline of patients with mild Alzheimer’s by targeting amyloid proteins in the brain. Amyloids accumulate in the sticky brain plaques that are a hallmark of Alzheimer’s disease. The proteins disrupt cell-to-cell communication and eventually cause brain cell death.

Dr. David Geldmacher is a professor in UAB’s Department of Neurology and the co-director of the UAB Alzheimer’s Disease Center. He says this new treatment is an important step.

“Our prior treatments treat the symptoms of the illness. They help the brain cells work better, but this is the first of the treatments that is believed to slow down the progression and remove some of the abnormal chemical accumulations in the brain that occur in Alzheimer’s disease.”

Dr. David Gelmacher

The Alzheimer’s Association of Alabama was also involved in Aduhelm’s development. They provided the initial seed money for the development of amyloid PET scans that made the clinical trials possible. These funds come from events like the Heart of Alabama Walk to End Alzheimer’s in Birmingham. Jessica Miller, the executive director of Alabama’s Alzheimer’s Association chapter, is hopeful about the new drug.

“This approval ushers in a new era in Alzheimer’s treatment and research. History has shown us that the approval of the first drug in any category will invigorate the field, increase investment in new treatments and generate greater innovation.”

Jessica Miller

More testing expected

A second study is underway to determine Aduhelm's ongoing effectiveness. Photo courtesy of Alzheimer's Association of Alabama.
A second study is underway to determine Aduhelm’s ongoing effectiveness. Photo courtesy of Alzheimer’s Association of Alabama.

Aduhelm is approved under special authority. The designation is given for drugs that treat high need populations. Alzheimer’s fits that profile.

Dr. Gelmacher noted there was controversy in Aduhelm’s approval process. The drug’s two clinical trials were terminated early because it didn’t seem effective initially. After those early terminations, scientists reanalyzed the data. The combined results showed a 20% efficacy in slowing the course of Alzheimer’s.

A second study will determine Aduhelm’s long term effectiveness. There’s a chance it could be proven ineffective. Even so, its approval is a step in the right direction.

“I’ve been involved in drug testing for Alzheimer’s disease for 28 years. This medication will provide important benefits for some people, but it leaves the door open for us to find better treatments and better therapies. That’s the focus of our ongoing research. This is not a door closing on the research process. This is a door opening to look at new ways of supplementing this medication’s effectiveness.”

Dr. David Gelmacher

More than 6 million Americans are living with Alzheimer’s today. This approval is a victory for people living with Alzheimer’s and their families.

For more on UAB’s innovative research, click here.

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