Approval of Disputed Alzheimer’s Drug Causes FDA Adviser Resignations

treatment for neurodegenerative disease causes waves at advisory committee

By Jonny Lupsha, Wondrium Staff Writer

Alzheimer’s disease is responsible for 60% to 80% of dementia cases. More than six million people live with Alzheimer’s, which is a progressive and terminal neurodegenerative disease. Three FDA advisers resigned after a controversial treatment drug was approved.

Older man and woman, dealing with Alzheimers disease
Alzhiemer’s disease is known for severe symptoms of forgetfulness and misidentifying people and objects. Photo By LightField Studios / Shutterstock

For the first time in 20 years, the FDA approved a drug intended to treat Alzheimer’s disease. However, evidence of its effectiveness has been weaker than many scientists would like—so much so, in fact, that three advisers have resigned in protest of the approval. Their committee rejected the drug after reviewing clinical trial data in November after deciding it was both ineffective to slow cognitive decline and could produce serious side effects.

Alzheimer’s patients and their caregivers already have plenty to overcome. In his video series Memory and the Human Lifespan, Dr. Steve Joordens, Professor of Psychology at the University of Toronto Scarborough, explained the progression of the disease and symptoms that patients may exhibit.

Early Stages of Alzheimer’s

According to Dr. Joordens, the progression of Alzheimer’s disease is typically divided into three stages. However, they sometimes seem to be preceded by a preliminary stage of milder impairment that isn’t severe enough to be diagnosed as Alzheimer’s; so it’s not clear yet whether this preliminary stage is definitively linked to Alzheimer’s or not.

“Generally, the disease targets memory systems, and it destroys them in almost the order that’s the reverse of how they were built up earlier in life,” Dr. Joordens said. “Early on, it is the episodic memory of most recently learned information that is most likely to be impaired.”

Unfortunately, this sort of memory loss is typical of normal dementia, so it can be difficult to differentiate between the two in the preliminary and early stages of Alzheimer’s. They may also experience near-total memory loss like forgetting who or where they are, but patients tend to recover quickly from these bouts of forgetting and may be too embarrassed to discuss them.

“Patients also become very hyperactive,” Dr. Joordens said. “They may have really serious problems sleeping at night, and they may sometimes just feel they have to get out and walk. Of course, at a very general level, exercise is great; however, it becomes dangerous when a loss of self-awareness occurs while a patient is walking.”

Clearly, the need to be brought home by a stranger—or a police officer—and then be cared for is taxing on the patient and the caregiver.

Advanced Alzheimer’s

Soon, the patient moves into what’s called the moderate stage of Alzheimer’s. Dr. Joordens said that from a memory perspective, this is where doctors begin to see further deteriorations in semantic and procedural memory.

“Patients forget how to brush their teeth; they may forget how to dress, how to take a shower, how to do many of those things they used to do routinely and do on their own,” he said. “Even their habits are lost, and without reliable habits, they also lose their independence. At this point, they need a lot of assistance just to function.”

The moderate stage of Alzheimer’s is when many caregivers will move a patient into a nursing home, though others who fear distilling a sense of abandonment in the patient will try to avoid moving them into a home for some time. Other symptoms of the moderate stage of Alzheimer’s include further language impairment, more pronounced wandering, and a stronger effect on the patient’s mood.

“In the advanced stage of Alzheimer’s, patients are completely dependent on the care of others,” Dr. Joordens said. “Language is reduced to just words or very short phrases; patients typically exhibit exhaustion and will not be able to perform even the simplest task without assistance. Sometimes during this stage, patients typically become bedridden and eventually they will pass away, though typically not from the disease itself.”

Often, Alzheimer’s patients die of pneumonia, adrenal failure, or another failure of some critical system in the body.

There is currently no cure for Alzheimer’s, and it is a heartbreaking disease for both the patient and the caregiver to face. However, exercise and a solid social structure seem to alleviate cognitive decline, including leading to better memory skills.

Edited by Angela Shoemaker, Wondrium Daily