The End of Alzheimer’s: Predicting the Decline of Memory and Thinking Using an Epidemiologic Trial on a Woman’s Brain

The study comes after several experimental drugs have failed to prevent declines in memory and thinking even though they succeeded in removing amyloid from the brains of patients in the early stages of Alzheimer’s. The idea that amyloid is the cause of a cascade of events that lead to the death of brain cells has been eroded by those failures.

“We think of that as the final test of the amyloid hypothesis,” says Randall Bateman, a professor at Washington University School of Medicine. Nothing will work that way.

Alzheimer was given the chance to conduct an autopsy on a woman who died after suffering memory loss, disorientation, and hallucinogens. He observed that the woman’s brain had an “unusual disease of the cerebral cortex,” including “senile plaque” usually seen in much older people.

Penicillin failed its first two clinical trials. “Fortunately, people didn’t say, oh, the antibiotic theory is a bad idea and we should give up on it.”

At the meeting, researchers presented results of a study of nearly 1,800 people in the early stages of Alzheimer’s. The decline in memory and thinking was reduced by 27% for those who received lecanemab for 18 months.

He predicts that it will work, and that it will work well. If we can prevent plaques from taking off and downstream changes from happening, I think the people will never get Alzheimer’s.

These changes include the appearance of toxic tau tangles inside neurons, the loss of connections between neurons, inflammation, and, ultimately, the death of brain cells involved in thinking and memory.

Why do some people with Alzheimer’s disease experience the initial stages of aphasitogenesis? The decision to enroll Aduhelm in a Phase I Clinical Trial may not get FDA approval

“The earliest they can come in is 25 years before we anticipate they would start to develop symptoms,” McDade says. When we’re going to start this trial, that puts most of the families in their mid 20s.

“If we prevent amyloid pathology from developing and these other markers continue to develop and unfold,” McDade says, “this would be one of the best ways to say, listen, amyloid is really not what we should be targeting.”

“There was a feeling of elation, like this was a milestone in the fight against Alzheimer’s disease,” says Dr. Eric Reiman, executive director of Banner Alzheimer’s Institute in Phoenix.

Alzheimer’s shrinks the brain, a sign that the cells in it are dying. Alzheimer’s drugs were expected to limit the damage rather than accelerate it.

Since then, the federal Medicare program has decided it will cover Aduhelm treatment only for patients enrolled in a clinical trial. There have been few patients who have received the drug as a result of that decision.

“It had effects on a range of cognitive and functional measurements that are important to families and family caregivers,” Reiman says. ” I will be surprised if it does not get full approval” from the FDA.

The FDA could decide this week if it will grant accelerated approval for lecanemab, according to the companies that make the drug.

There are still concerns about lecanemab, a drug that removes amyloid from the brain. The most common concern is a condition called ARIA oramyloid-relatedimaging abnormality.

In rare cases, though, patients can experience brain damage or even death. So far, two deaths have been linked to lecanemab, although both patients had other conditions that could have contributed to the outcome.

“What we’ve learned over time is that a very small proportion of individuals will have symptoms,” Cohen says, “and when symptoms arise, they are usually transient, mild to moderate, and resolve.”

Some people with ARIA may not have any symptoms at all, but can end up in the hospital after a while. People who have a genes called APOE4 can be at greater risk for Alzheimer’s disease and other dementias. ARIA were not as common among noncarriers.

“It’s incumbent upon drug developers and researchers to try and prove that these changes are benign and do not represent a significant adverse event,” he says.

CMS’s request asking for full and unrestricted coverage of FDA-approved Alzheimer’s treatments: The case of lecanemab

“The Alzheimer’s Association has filed a formal request asking CMS to provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments,” Carrillo said.

The results also showed that about 6.9% of the trial participants given lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared with 2.9% of those given a placebo. There were 14 serious adverse events in the lecanemab group.

Even if the FDA offers accelerated approval of the drug, it will still be studied in more robust trials. And if those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval. FDA has procedures to take a drug off the market if it doesn’t show benefit in a confirmatory trial.

The Alzheimer’s Association says there are more than 300 Alzheimer’s treatments in clinical trials. Alzheimer’s disease was first described in 1906 when Dr. Alois Alzheimer discovered changes in the brain tissue of a woman who had memory loss.