Subduction Zone
Veteran Member
First the setup . There are potentials to use monoclonal antibodies in Alzheimer treatments. This is the story of one that has advanced to human testing:
https://www.cms.gov/newsroom/press-...antibodies-directed-against-amyloid-treatment
From the article:
But when this drug goes wrong it can go wrong in a big way:
Science | AAAS
With only moderate improvements and a possible time bomb waiting to go off in many patients it appears that this drug will not be approved.
https://www.cms.gov/newsroom/press-...antibodies-directed-against-amyloid-treatment
From the article:
CONCLUSIONS
Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.
But when this drug goes wrong it can go wrong in a big way:
Science | AAAS
A 65-year-old woman who was receiving a promising experimental treatment to slow the cognitive decline caused by her early Alzheimer’s disease recently died from a massive brain hemorrhage that some researchers link to the drug. The clinical trial death, described in an unpublished case report Science has obtained, is the second thought to be associated with the antibody called lecanemab. The newly disclosed fatality intensifies questions about its safety and how widely lecanemab should be prescribed if ultimately approved by regulators.
. . .
“It was a one-two punch,” Castellani says. “There’s zero doubt in my mind that this is a treatment-caused illness and death. If the patient hadn’t been on lecanemab she would be alive today.” (Castellani says his comments reflect personal views and were not reviewed or approved by Northwestern. The patient’s husband told Science he authorized Castellani to speak publicly about his wife’s case. Science agreed to withhold both names to protect the family’s privacy.)
. . .
<the man's wife had suffered a stroke, possibly brought on by this new drug. He took her to the ER for treatment and this describes here reaction to the medicine that she received>
“Her body was on fire”
When speaking to Science last week, the dead woman’s spouse was at times overcome by emotion as he described a shattering and chaotic scene after his wife entered the emergency department with stroke symptoms. He informed the doctors about the lecanemab trial and contacted Great Lakes, which provided a web link to information about the antibody. After the attending physician reviewed the website, the care team proposed infusing tPA, describing its risks as relatively small.
“As soon as they put it in her, it was like her body was on fire. She was screaming, and it took like eight people to hold her down,” the husband says. “It was horrific. Everybody's running in and [asking] ‘What the hell is going on?’” His wife was sedated and moved into intensive care, he adds. A priest came to deliver the “Anointing of the Sick” prayer.
Soon after, the husband says, his wife suffered a series of seizures and was placed on a ventilator. A few days later, the family approved disconnecting the device, and she died. Her doctors told him they had never before seen such massive bleeding under those circumstances, and that they wanted to write up the details of the case for a medical journal.
With only moderate improvements and a possible time bomb waiting to go off in many patients it appears that this drug will not be approved.