An experimental drug from the biotech company
Pneumonia and deaths were more common among those receiving the drug, but researchers downplayed that. Study leader Dr.
"We're very encouraged" by the hint of benefit for patients with milder dementia and will talk with regulators about next steps for the drug, crenezumab (cruh-NEZ-oo-mab), said a
Results were revealed Wednesday at the Alzheimer's
They are the latest mixed bag on treatments aimed at clearing away the sticky amyloid plaques clogging Alzheimer's patients' brains. About 35 million people worldwide have Alzheimer's, the most common form of dementia. There is no cure and current treatments only temporarily ease symptoms.
Last year, an
Mid-stage studies aim to give some idea of safety and whether the drug is effective enough to advance to larger, more definitive studies aimed at winning market approval.
In one study, 431 patients ages 50 to 80 with mild to moderate Alzheimer's were given crenezumab or dummy drug as shots every two weeks, or as a higher dose in infusions every four weeks for 17 months. No significant difference was seen among the groups on two widely used measures of thinking and functioning skills.
However, the 70 most mildly impaired participants who received the higher dose declined 35 percent less on the cognitive measure than the 33 mildly impaired people given dummy infusions. The difference was about 3.5 points on the roughly 70-point scale — "equivalent to six or nine months" of delay in decline, Cummings said.
This result isn't definitive, though, and can only be considered a signal worth exploring in future research because it didn't involve the whole group tested. And even in this mildly impaired group, the drug did not improve the second measure, ability to function in daily life.
In the second study, 73 people who showed amyloid plaques on brain imaging also were given crenezumab or dummy shots or infusions. The main outcome — levels of amyloid seen on brain imaging after treatment — will be presented at a medical conference in November. Results on cognitive function seem to mirror those in the larger study, Cummings said.
Five people given crenezumab died — one from sudden death, two from respiratory failure, one from pneumonia and one from worsening Alzheimer's.
"We believe that the safety profile is acceptable," because deaths do not seem related to the drug,
In a statement Wednesday, the
Patient, family info: http://www.alzheimers.gov/
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