Karen Kier, Pharmacist
on behalf of the ONU HealthWise team

ONU HealthWise Pharmacy
419-772-3784
www.onuhealthwisepharmacy.com

Alzheimer’s disease (AD) is a form of dementia that affects 6.2 million Americans.

Dementia is a broad-based group of disorders that change mental processes caused by brain disease or injury resulting in memory disorders, personality changes, and impaired reasoning. 

Alzheimer’s disease is the most common form of dementia accounting for 60-80% of the dementia disorders. The underlying cause for why AD causes memory loss is not completely understood.  Autopsy data over the years has shown that patients with AD had an increase in amyloid plaques. 

So research studies looking for cures for AD have included a focus on decreasing the amyloid plaques in the brain or preventing plaques from developing.  In addition to the amyloid plaques, AD patients have an increase in neurofibrillary tangles also known as tau that results in a loss of neurons (nerve cells).

These tangles reduce the ability of nerve or brain cells to make connections resulting in the memory loss. Early research in reducing amyloid plaques has not revealed a successful cure or treatment to date. 

On June 7, 2021, the Food and Drug Administration (FDA) approved the first new drug for Alzheimer’s disease (AD) in 18 years.

The FDA approved the drug known by the generic name of aducanumab and the brand name of Aduhelm. The drug went through the FDA’s accelerated or fast track approval process.

The FDA approved the drug for all Alzheimer’s disease patients.  Biogen is the company that has been researching this drug.  Three clinical studies have been completed in humans with early-stage AD with mild cognitive impairment.  The three studies involved 3,482 patients, which included a comparison of aducanumab to a placebo (no drug) group.

The drug is an intravenous infusion that must be infused over 1 hour. The drug must be administered every four weeks. The studies evaluated a surrogate biomarker rather than clinical improvement of memory or at least a slowing of the profession of the disease. 

The biomarker evaluated was the amount of amyloid plaque in the brain. The studies did show a decrease in amyloid plaque in the active drug group compared to no decrease in the placebo group. One of the significant side effects of the active drug is called ARIA, which stands for Amyloid Related Imaging Abnormalities.

ARIA can result brain swelling and small bleeds in the brain.  Patients on this medication need to evaluated and monitored by MRI scans. Patients are advised to report headaches, falls, confusion, changes in mental status, or diarrhea. 

This approval may seem like a major advance in the fight for AD but this FDA approval has resulted in a different fight. The FDA advisory panel of experts who evaluated this drug voted against the approval of this drug. 

Ten of the 11 experts voted no. The FDA decided to approve the drug despite the expert scientists disagreeing.  The FDA has the authority to approve a drug despite expert dissention.

The fight has gotten uglier with three of the medical experts resigning from the advisory panel. Dr. Aaron Kesselheim, a professor from Harvard College of Medicine, resigned after the FDA decision after he voted no. Dr. Kesselheim had been on the advisory panel for six years prior to this approval. The physician expert was quoted as saying, “this might be the worst approval decision that the FDA has made that I can remember”. 

Another neurology physician from the Mayo Clinic also resigned from the committee based on opposition to the decision.  Dr. David Knopman stated in his resignation that “biomarker justification for approval in the absence of consistent clinical benefit after 18 months of treatment is indefensible’. 

The experts point out that the drug was approved on a reduction of amyloid plaques but not on the clinical progression of the disease or patient symptom improvement.

In addition, the physicians had a concern that the studies were in early disease patients but the FDA approved the drug for all patients with AD.  No data has been collected on advance disease. The FDA has stated that the approval of this drug will continue to be evaluated as more information is gathered.

This new drug illustrates the difficulty in trying to find solutions to serious problems such as AD and the hope for new treatments. The fight to find new treatments continues.

The Ohio Northern University Drug and Health Information Center (DHIC) is available to answer questions related to medication and health information. The pharmacists and student pharmacists that answer questions are very well versed on the COVID-19 vaccines as well.

The website to submit a question to the DHIC is https://www.onu.edu/student-life/health-and-wellness-resources/onu-healt.... Feel free to call the ONU HealthWise Pharmacy or talk to your health care professional for more information.