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Recruitment has begun for a Phase 2 clinical trial that’s evaluating Cognition Therapeutics’ once daily oral therapeutic candidate Elayta in adults with early Alzheimer’s disease. START (NCT05531656) expects to enroll about 540 adults, ages 50-85. The University of Kentucky Sanders-Brown Center on Aging (SBCoA) is the first to…

The U.S. Food and Drug Administration (FDA) has granted full approval to Eisai and Biogen’s Leqembi (lecanemab), the first treatment shown to slow disease progression in adults with early Alzheimer’s disease. Leqembi won accelerated (conditional) approval in January based on Phase 2 trial data that showed it…

On-demand treatment with BXCL501, an orally dissolving film formulation of dexmedetomidine, significantly eased episodes of agitation among Alzheimer’s disease patients in a Phase 3 clinical trial, according to topline results announced by the therapy’s developer, BioXcel Therapeutics. “We believe these results represent a significant milestone for BioXcel Therapeutics…

In the earliest stages of Alzheimer’s disease, even before cognitive symptoms have become apparent, there are detectable changes in the makeup of bacteria in the gut, a study shows. The finding suggests that analyses of gut bacteria may help identify early Alzheimer’s, according to researchers. “By the time…

A U.S. Food and Drug Administration (FDA) advisory committee has decided that data from the Phase 3 Clarity AD trial are sufficient to confirm the clinical benefits of Leqembi (lecanemab) for the treatment of early Alzheimer’s disease. The FDA now will consider the unanimous opinion of the committee…

A blood test that checks for the abnormal activation of star-shaped cells in the brain called astrocytes may be able to identify people who are more likely to develop Alzheimer’s disease, a new study suggests. “Our study argues that testing for the presence of brain amyloid along with blood…

For many people, the month of June is for cookouts, picnics, and hanging out at the beach. For the Alzheimer’s disease community, though, it’s also Alzheimer’s and Brain Awareness Month — a time for educating others about the progressive neurodegenerative disorder and advocating for the approximately 55 million…

Eisai and Biogen are seeking approval in Canada and the U.K. for lecanemab to treat early Alzheimer’s disease. It’s available under the name Leqembi in the U.S. Health Canada has accepted the application for review, while the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA)…

“Encouraging results” were reported in eight Alzheimer’s disease patients with dementia who were treated with COYA 301, an experimental therapy being evaluated in a small clinical trial, according to Coya Therapeutics, its developer. “Results of our open-label proof-of-concept study with COYA 301 in 8 patients with Alzheimer’s showed…

Donanemab significantly slowed the decline of cognitive and functional abilities in people with early Alzheimer’s disease, according to top-line data from a Phase 3 clinical trial. Based on these findings, Eli Lilly, its developer, plans to ask the U.S. Food and Drug Administration (FDA) to approve it within the…