
"Those participants, initially diagnosed with mild cognitive impairment rather than mild dementia, "showed very meaningful responses," says Dr. Susan Abushakra, chief medical officer of Alzheon, the drug's maker. By one measure, the drug slowed cognitive decline by 52% in people with mild cognitive impairment. That result appears comparable with benefits from the two Alzheimer's drugs now on the market: lecanemab and donabemab."
"More robust results came from measures of brain atrophy the shrinkage that tends to come with Alzheimer's. In the hippocampus, for example, participants who got ALZ-801 experienced about 18% less atrophy than those who got a placebo. That's an important difference, Abushakra says, because the hippocampus is critical to memory and thinking."
Topline results from a trial of ALZ-801 in more than 300 genetically predisposed adults initially showed no overall benefit versus placebo. A subgroup analysis of 125 participants with mild cognitive impairment showed meaningful responses, with one measure indicating a 52% slowdown in cognitive decline; the small subgroup size limits precise quantification. Brain-imaging measures showed about 18% less hippocampal atrophy with ALZ-801 versus placebo, a neurologically important difference. The findings were published in Drugs and supported by a $47 million NIH grant. ALZ-801 may receive special consideration because it could offer advantages over intravenous monoclonal-antibody therapies, which add cost and require infusion visits.
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