cflegal wrote:I certainly want to hear more. Aducanumab removed amyloid below the level of PET scan detectability! At the same time, however, memory decline was only slowed and not reversed. We will never know what a "lifestyle" component to the study would have provided.
Theracurmin (curcumin) is the only other approach the I know of that has removed amyloid plaque (Dr. Gary Small, UCLA). This year we will probably get results from Sally Frautschy's trial at UCLA and the West LA VA Center with Longvida brand of a curcumin product.
tinamalone wrote:Are most people taking a Longvida form of curcumin? What about Thorne's Meriva form?
By June, as Biogen analyzed the full data set, researchers started to realize that a different picture was emerging of aducanumab, Sandrock said. The reason was because of changes that Biogen had made to the study late in the game. Initially, the company worried about a potential side effect — brain swelling — and limited the dosage of the drug. But later patients were allowed to receive higher doses of the medicine.
“In retrospect, the results of the futility analysis was incorrect,” Sandrock said. “That’s because it was from a smaller dataset that looked at patients with less exposure to high dose aducanumab.”
In essence, Sandrock said, the futility analysis had happened too soon. It had looked at data based on last December. But the trials were actually stopped in March. Biogen had run two studies. One, was positive in its own right for the high dose. A second still failed, but shows signs of benefit in those patients who received the higher dose of aducanumab.
Biogen said that the new data show aducanumab is “pharmacologically and clinically active” and that it reduced patients clinical decline based on the results of a survey called Clinical Dementia Rating-Sum of Boxes (CDR-SB), which was the study’s main goal.
Susan,SusanJ wrote:So, Biogen is asking the FDA to approve aducanumab, based on a new data analysis.
https://www.creativebiolabs.net/aducanumab-overview.htm [emphasis added]Aducanumab...is a human IgG1κ monoclonal antibody...derived from...cells collected from healthy elderly subjects with no signs of cognitive impairment, and cognitively impaired elderly subjects with unusually slow cognitive decline...
In patients with prodromal or mild AD, one year of monthly intravenous infusions of aducanumab reduces brain Aβ [amyloid beta] in a dose- and time-dependent manner
Julie G wrote: I'd love to see the primary evidence and compare the before and after CDR-SB scores. Has anybody seen it?
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