The Alzheimer’s drug being tested by Penn Medicine has been approved by the Food and Drug Administration


Campus Penn Medicine on October 3, 2020. Credit: Max Meester

The Federal Drug Administration recently approved a drug being trialled by the Penn Memory Center to reduce the risk of Alzheimer’s disease.

The medicine, Leqembi, earned FDA approval Under Expedited approval process On January 6, a trial after AHEAD evaluated its effectiveness on volunteers is over its third stage. The researchers were at Penn Medicine Study volunteers Those who do not have severe symptoms of dementia but may be at risk of developing it in the future, as the study aims for preventive prevention of symptoms.

As of September, the AHEAD clinical trial has studied nearly 1,800 individuals. These trials reported a 27% improvement in slow or low cognitive decline compared to those who received a placebo.

David Wolk, co-director of the Penn Memory Center and director of the Alzheimer’s Disease Research Center in Pennsylvania, wrote in statment These findings are a “very encouraging development”.

Leqembi aims to reduce the damage caused by amyloid proteins, which may be associated with impairments in memory and thinking. Amyloid proteins are found in higher amounts in the brains of Alzheimer’s patients.

The recent FDA approval did not consider data and results from the Phase 3 trials of Leqembi. stay there they about the drug’s long-term effects, as three patients enrolled in the trial had recently died of brain hemorrhage and swelling complications. Some researchers have claimed these deaths may be related on drugs.

The drug has the potential to reproduce naturally in humans, Sanjeev Vaishnavi, MD, a neurologist at Penn Medicine, told The Daily Pennsylvanian.

“[The drug] “It is actually derived from the blood of older individuals who did not have Alzheimer’s disease,” Vaishnavi said. “It’s one of these few things that kind of started out in humans, went to the lab, and now it’s back in humans.”

Much of the research with Leqembi up to this point has shown that it slows memory decline in patients who already have Alzheimer’s symptoms. Vaishnavi said the AHEAD study now hopes to slow the process of acquiring symptoms in the first place.

Previously, drugs aimed at combating memory loss had little clinical success. This lack of success has led some doctors to speculate that amyloid proteins are not a cause of Alzheimer’s disease, but rather an occasional side effect.

An alternative explanation given by some doctors is that a protein called tau is the primary culprit in Alzheimer’s disease. Virginia Man-Yi Lee, director of the Neurodegenerative Disease Research Center at the Perelman College of Medicine, has led the search on Tao.

In general, Alzheimer’s disease researchers have faced many challenges while trying to explore the disease. For example, symptoms of Alzheimer’s disease come and go over many years, which means clinical trials have to go on for long periods of time, Vaishnavi told DP.

“Speed ​​things up and identify the right individuals to search… [is] “The work we continue to do going forward,” Vaishnavi said. Hope is if [Leqembi] It works for people with more significant memory loss symptoms, and it may work better for people early on. This is the process of thinking about the big picture.”

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