On Sola - (http://www.dddmag.com)
“The statistical analysis reported today does not provide any information on efficacy or on the amyloid hypothesis,” Dr. Lon Schneider, professor at the University of Southern California, told The New York Times.
Maria Carillo, Ph.D., chief science officer for the Alzheimer’s Association, told The Street: “I think the data show hopefulness for the approach...but you can’t draw too many conclusions. This is not a blockbuster cure, but it may be slowing down the decline” in Alzheimer’s patients.
From The Street -
But not all Alzheimer's experts share Lilly and Aisen's optimistic view of the sola delayed-start data. An Alzheimer's doctor at the AAIC conference, who asked not be named because he didn't want to criticize colleagues publicly, views the small differences in measurements of cognition and function between early- and delayed-start sola patients to be clinically meaningless.
He also believes Lilly leaned heavily on extensive "modeling" of the raw data and unproven but generous statistical methods to reach its positive conclusions. "What we're seeing here is not a disease modifying effect," he says.
Biogen’s Aducanumab (http://www.dddmag.com)
Biogen presented data on its 6 mg dose of aducanumab today, but results were mixed. The 6 mg dose significantly reduced beta amyloid plaque in the brain, but failed to significantly slow mental decline.
In March, Biogen’s aducanumab became the first experimental drug to significantly reduce beta amyloid in the brain and slow cognitive decline in patients with mild disease, according to 54-week data from a small, early-stage trial. These results were seen at doses of 3 mg and 10 mg— but while the 10 mg dose was most
effective, it had a high rate of localized swelling in the brain.
Researchers were hopeful the 6 mg dose would provide the right combination of effectiveness, with less of a brain-swelling side effect seen with other doses. But this middle dose, tested in 30 patients, did not reduce cognitive decline by a statistically significant amount on either of two measures following a year of treatment. The side-effect rate was also still relatively high.http://www.dddmag.com/
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On Sola - (http://www.dddmag.com) “The statistical analysis...
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