Axsome to ask FDA to approve AXS-05 for Alzheimer’s agitation. Axsome Therapeutics plans this year to ask the U.S. Food and Drug Administration (FDA) to approve its oral therapy AXS-05 as a treatment for agitation related to Alzheimer’s disease.

2024年2月8日 · Two Phase 3 clinical trials are testing the effectiveness of simufilam, an experimental oral therapy that’s designed to improve cognition in people with Alzheimer’s disease.. Top-line results from the RETHINK-ALZ trial (NCT04994483) are expected by the end of this year, according to simufilam’s developer Cassava Sciences.Results from the second study, REFOCUS-ALZ study (NCT05026177), are ...

Modified Kisunla dosing shown to lower risk of ARIA-E in Alzheimer’s. Being started on a smaller dose of the approved early Alzheimer’s disease therapy Kisunla (donanemab) — by shifting one vial from the first to the third infusion treatment — reduces the risk of ARIA-E, or amyloid-related imaging abnormalities associated with brain swelling, among adults with the neurodegenerative ...

2023年9月22日 · These are the top-line findings of an ongoing Phase 2 clinical trial (NCT04693520), whose two-year data also showed that Alzheon’s experimental therapy preserved the hippocampus, a brain structure important for memory that is damaged first in Alzheimer’s.. Importantly, ALZ-801’s safety profile over two years continued to show no increased risk of brain swelling and bleeds, which have ...

2021年1月25日 · The device uses gamma frequency technology — called GENUS, for gamma entrainment using sensory stimuli — as a way to stimulate the brain in a non-invasive way.This can be done as an auditory (via sound) or visual (via light) stimulation. In mouse models of Alzheimer’s disease, researchers had already observed that, prior to the onset of cognitive decline, the brain showed a pattern of ...

2024年9月26日 · The board’s findings were announced by therapy developer Cassava Sciences, which said in a press release that the company expects to share data from one clinical trial later this year, and from the other by the middle of next year.. The two trials, dubbed RETHINK-ALZ (NCT04994483) and REFOCUS-ALZ (NCT05026177), have collectively enrolled 1,929 people with mild to moderate Alzheimer’s.

2024年8月1日 · In Alzheimer’s, misfolded proteins build up into toxic clumps that disrupt the normal functioning of nerve cells, leading to brain damage. This slowly impairs memory and thinking skills, and eventually the ability to carry out the simplest tasks in daily life. “People living with early Alzheimer’s disease have the desire to maintain their sense of self for as long as possible,” said ...

2023年4月21日 · The findings expand on data from a completed Phase 2a trial (NCT05074498) that preceded the OLE (NCT05476783) that showed a month of TB006 improved clinical signs, but failed to reach statistical significance compared with a placebo. “The three month or longer treatment in the OLE led to disease reversal or stabilization in the majority of participants with mild, moderate to severe ...

2021年1月4日 · “As a company we aspire to address high unmet medical needs within serious chronic diseases, and we are therefore pleased to initiate phase 3 development of semaglutide within Alzheimer’s disease,” Mads Krogsgaard Thomsen, PhD, executive vice president and chief scientific officer at Novo Nordisk, said in a press release.. Semaglutide is approved in the U.S., EU, and Japan, under the ...

2024年7月3日 · Specifically, Kisunla is indicated for patients with early symptomatic Alzheimer’s — to include individuals with mild cognitive impairment or mild dementia, and confirmed evidence of amyloid plaques, the toxic protein aggregates, or clumps, that accumulate in the brain of those with the neurodegenerative disease.