Today is the first class of our new November class period. The start time for our class will be 10:00am. We will begin class with a casual conversation. Our reading today is about submarines. Please try to read as much as possible. Underline any words or sentences that are unfamiliar. Our listening is about an Alzheimer’s pill. Please listen and follow the transcript. We will complete our grammar sentences.
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JUANA SUMMERS, HOST:
Six months ago, the future was looking bleak for an Alzheimer's drug called ALZ-801. Now, a new study suggests the drug could help some people whose genes put them at high risk for Alzheimer's. NPR's Jon Hamilton reports.
JON HAMILTON, BYLINE: In April, the biotech company Alzheon announced that its drug ALZ-801 had come up short. A large trial of people genetically predisposed to Alzheimer's found that overall, those who got the drug did no better than those who got a placebo. But Dr. Susan Abushakra of Alzheon says a closer look showed that one group did benefit.
SUSAN ABUSHAKRA: The group that's at the early stages of mild cognitive impairment - MCI - where most of what they had was memory problems actually showed very meaningful responses on cognition and on function and on brain volume.
HAMILTON: The findings were published in the journal Drugs, and Abushakra says they showed that on some measures, ALZ-801 slowed down Alzheimer's as much as the two existing drugs.
ABUSHAKRA: The cognitive tests that are memory and calculation and language, that showed slowing of the decline by 52% compared to the placebo arm.
HAMILTON: She says the drug also kept brain areas, including the hippocampus, from shrinking as much.
ABUSHAKRA: And that's really important because of course the neurons in the hippocampus is what serves our memory - what gives us memory and good cognition.
HAMILTON: The results are open to interpretation because they excluded participants with more severe symptoms. But ALZ-801 may get special consideration because it's unlike the two existing drugs. Those drugs, lecanemab and donanemab are monoclonal antibodies given by intravenous infusions. ALZ-801 is a pill. Also, the monoclonal antibodies work by breaking down sticky amyloid plaques. Abushakra says Alzheon's product keeps the plaques from forming in the first place.
ABUSHAKRA: With our drug, we actually target amyloid at a very early stage. We target the clumping or aggregation of the amyloid.
HAMILTON: As a result, ALZ-801 doesn't cause the swelling or bleeding in the brain that often comes with monoclonal antibody treatment, and that's critical for people who carry two copies of a gene called APOE4. Their genetic status means they have at least 10 times the usual risk of developing Alzheimer's. And Jessica Langbaum of Banner Health in Phoenix says they're also more likely to experience side effects from existing drugs.
JESSICA LANGBAUM: These individuals are at higher risk for some adverse events - inflammation in the brain, if you will - and that can be quite serious.
HAMILTON: Even fatal. So Langbaum says doctors are often reluctant to give lecanemab or donanemab to these people who make up about 15% of all Alzheimer's patients.
LANGBAUM: There's quite a lot of discussion going on in the field, and clinicians vary whether they will want to prescribe one of these new treatments to people with two copies of the APOE4 gene.
HAMILTON: Langbaum isn't sure that people with the APOE4 gene need a different drug. But the idea appeals to David Watson, a scientist who carries two copies of the APOE4 gene. Watson, who runs the Alzheimer's Research and Treatment Center in Florida, is a co-author of the new study. He notes that the drug reduced levels of a protein fragment associated with brain cell death.
DAVID WATSON: We're really making a difference in keeping neurons alive. We're actually seeing changes that we typically don't see in the monoclonal antibody studies.
HAMILTON: More evidence of the drug's effectiveness is coming from people who kept taking ALZ-801 after the initial 18-month study period ended. Because they carry two copies of the APOE4 gene, scientists expected them to decline more quickly than other Alzheimer's patients. But Watson says for at least some participants, that hasn't happened.
WATSON: Functionally, these individuals didn't deteriorate, and many of them are on an extension phase now well past the 18 months and kind of holding their own.
HAMILTON: Alzheon says it's working with the Food and Drug Administration to assess this new information.