Penn Medical Campus on October 3, 2020. Credit: Max Meister 
The Federal Drug Administration recently approved a drug tested at the Penn Memory Center to reduce the risk of Alzheimer’s disease.
The drug, Lekembi, received FDA approval on Jan. 6 through an accelerated approval process after the AHEAD trial completed its Phase III trial in volunteers. Penn Medical researchers have been studying volunteers who do not show severe symptoms of dementia but may be at risk for future development, with the study aimed at preventing early symptoms.
As of September, the AHEAD clinical trial has studied nearly 1,800 individuals. These trials reported a 27% improvement in delayed or reduced cognitive decline compared to those who received placebo.
David Wolk, associate director of the Penn Memory Center and director of the Alzheimer’s Disease Research Center at Penn, wrote in a statement that these results are “a very encouraging development.”
Lekembi aims to reduce the damage caused by amyloid proteins, which can be associated with memory and cognitive impairment. Amyloid proteins are abundant in the brains of Alzheimer’s patients.
It does not include recent FDA approval data and the results of Lekambi’s Phase III trials. There are concerns about the drug’s long-term effects, as three patients enrolled in the trial recently died of complications from brain bleeding and swelling. Some researchers say these deaths may be related to the drug.
Sanjeev Vaishnavi, a neurologist at Penn Medicine, told The Daily Pennsylvanian that the drug has the potential to replicate naturally in humans.
“[The drug] The blood was obtained from individuals who were elderly and did not develop Alzheimer’s disease,” said Vaishnavi. “It’s one of those few things that started in humans, went into the lab, and is now back in humans.”
Most of the research done with lekambi to date has shown that it slows down memory loss in patients with Alzheimer’s symptoms. Now, the AHEAD study hopes to slow down the process of finding symptoms in the first place, Vaishnavi said.
Previously, drugs intended to fight memory loss did not have much clinical success. This lack of success has led some doctors to speculate that amyloid proteins are not the cause of Alzheimer’s disease, but rather an accidental side effect.
An alternative explanation offered by some clinicians is that a protein called tau is the primary cause of Alzheimer’s disease. Virginia Man-Ye Lee, director of the Perelman School of Medicine’s Neurodegenerative Disease Research Center, led research on Tau.
In general, Alzheimer’s researchers have faced many challenges while trying to diagnose the disease. For example, Alzheimer’s symptoms appear and worsen over many years, which means clinical trials need to be long-term, Vaishnavi told DP.
“Speeding things up and identifying the right individuals for research… [is] The work we are doing is moving forward,” said Vaishnavi. “If the hope [Leqembi] It works for people with more significant symptoms of memory loss, it can work even more for people who have had it before. That’s the biggest thought process.
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