INmune Bio received the green light for MINDFul, its Phase 2 trial of XPro1595 — an experimental treatment for Alzheimer’s disease — to begin in Canada. Health Canada, Canada’s regulatory health authority, issued a “no objection letter” where it gives the company official permission to test XPro1595 in…
About 1.5 years of treatment with lecanemab (BAN2401) — now under regulatory review in the U.S. — was found to significantly slow the progression of dementia symptoms in people with early-onset Alzheimer’s disease. That’s according to just-released full data from the Phase 3 Clarity AD clinical trial, which showed…
Note: The headline of this story was updated Dec. 1, 2022, to correct that the decision to continue the Phase 2/3 clinical trial of fosgonimeton was recommended by an independent data monitoring committee. A Phase 2/3 clinical trial evaluating Athira Pharma’s experimental therapy fosgonimeton (formerly ATH-1017) in people…
Acumen Pharmaceuticals’ investigational antibody ACU193 has been granted fast track status by the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. With this designation, the company is eligible for certain benefits to get a potential new treatment…
The experimental therapy gantenerumab did not significantly slow clinical decline in people with early Alzheimer’s disease, failing to meet a primary trial goal, data from the Phase 3 GRADUATE 1 and 2 studies showed. Gantenerumab’s ability to remove beta-amyloid — the protein that forms plaques in patients’ brains…
From sporting teal to getting a virtual memory screening, supporters across the U.S. are marking National Alzheimer’s Awareness Month, observed each November, to call attention to the progressive neurodegenerative disorder and the 6.2 million people it’s thought to affect. The Alzheimer’s Foundation of America (AFA) is offering a…
Alzamend Neuro is seeking regulatory approval to launch the first U.S. trial of ALZN002, its investigational vaccine for mild to moderate dementia related to Alzheimer’s disease. If the U.S. Food and Drug Administration (FDA) approves the company’s investigational new drug application (IND), Alzamend will start a Phase 1/2a…
The U.S. Food and Drug Administration (FDA) has greenlit Annovis Bio to conduct a Phase 2/3 trial to test its investigational treatment buntanetap in people with moderate Alzheimer’s disease. The study, expected to start later this year, follows the positive findings from a Phase 2a trial…
The fifth annual “Dance Party to End ALZ” is on tap for Sunday, Nov. 13, in Nashville, Tennessee, to support the Alzheimer’s Association’s research grant program. The star-studded night of music, dancing, and fundraising, which takes place at the Wildhorse Saloon starting at 6 p.m. CST, will be hosted…
Treatment with lecanemab (BAN2401), an experimental amyloid-targeting antibody, significantly slowed the progression of dementia symptoms among people with early Alzheimer’s disease in the Phase 3 Clarity AD clinical trial, Biogen and Eisai announced. Both companies, the therapy’s developers, plan to discuss these results with regulatory authorities in the U.S.,…
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