New Alzheimer’s drug approved
The new Alzheimer’s drug Lequembi has been fully approved by the FDA. Photo by AP News
By PJ Martin
Editor
The Herald-News
Many families have been touched by the loss of a loved one due to Alzheimer’s. It is a devastating disease that slowly takes the person you know and love and leaves them unable to remember their own family. Then it gradually takes away the body and finally their life.
A glimmer of hope has emerged with the announcement of the US Food and Drug Administration (FDA) granting full approval to the Alzheimer’s drug lecanemab marketed under the name Leqembi on July 7th. It is the first medicine proven to slow the course of this horrid disease.
“This treatment, while not a cure, gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love. While we continue efforts to discover new targets and test new treatments, people living with this fatal disease deserve the opportunity to discuss and make the choice with their doctor if an FDA-approved treatment is right for them,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
According to the Alzheimer’s Association, the drug works by reducing amyloid plaques that form in the brain, a prominent telltale feature in the brain of Alzheimer patients.
The clinical trials showed that if the amyloid was removed from the brain, it produced meaningful benefits to patients in the early stages of the disease.
In the third phase of the clinical trials, Leqembi slowed the cognitive decline by over 5 months compared to a placebo after 18 months of treatment. The progress is expected to be even more positive after the medication is taken for an extended period of time.
Clinical trial were carried out at the UK Sanders-Brown Center on Aging. Photo by UK HealthCare Brand Strategy
The drug has been on the market since January 2023 when the FDA gave it accelerated approval, but at that point, Medicare refused to cover it.
Now that the FDA has given its full approval to the drug, Medicare is expected to cover its costs. That’s great news for seniors, because the new drug comes with a whopping price tag of around $26,500 per year (that’s $2,208 per month).
The FDA has approved the drug; however, it needs to be given in the earliest phase of the disease to be fully effective in slowing the progression.
So how do you know if you have Alzheimer’s?
A doctor can order a blood test to detect amyloid levels, but the best detection at the moment is still an MRI. There is also a self-test for dementia called SAGE (self-administered gerocognitive exam), which is a short, pen-and-paper cognitive assessment tool designed to detect the early signs of cognitive, memory, or thinking impairments. This can help your doctors understand how well your brain is functioning.
The diagnostic process may soon have a better way of early detection as a research team at the University of Washington is developing a new blood test that can measure levels of amyloid beta oligomers in blood and/or spinal fluid samples long before symptoms begin to appear. Oligomers are amyloid beta proteins that misfold and clump together, forming small loosely compacted masses. The test is called SOBA (soluble oligomer binding assay) and is showing promising results in studies.
Valerie Daggett, a UW professor of bioengineering and faculty member, stated that other diseases could potentially be diagnosed with SOBA, “Not just Alzheimer’s, but also Parkinson’s, type 2 diabetes, and more. SOBA is picking up that unique alpha sheet structure, so we hope that this method can help in diagnosing and studying many other ‘protein misfolding’ diseases.”
To see how Alzheimer’s affects the brain, go to https://www.alz.org/alzheimers-dementia/what-is-alzheimers/brain_tour where you can get an anatomy lesson on how the brain works and see a comparison of a healthy brain versus a brain suffering from Alzheimer’s.
If you would like to read more about the clinical trials of this drug carried out at the University of Kentucky’s Sanders-Brown Center on Aging Clinic go to
Photo | vejthani.com
