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.

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 ...

Feb 8, 2024 · 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 ...

Jul 3, 2024 · 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.

Sep 22, 2023 · 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 ...

Jan 3, 2025 · The results from ACCORD-2 are largely consistent with an earlier study called ACCORD (NCT04797715) that also showed AXS-05 was better than a placebo at preventing agitation relapse in Alzheimer’s patients. “Agitation is one of the most troubling and consequential aspects of Alzheimer’s disease, poses significant challenges to both the patient and their family, and represents a high unmet ...

Sep 15, 2023 · The global Phase 2b/3 trial, called Anavex 2-73-AD-004 (NCT03790709), enrolled 509 people, ages 60-85, with mild cognitive impairments or mild dementia due to Alzheimer’s.The participants were randomly assigned to receive oral capsules of either one of two doses of Anavex 2-73 (338 patients) or a placebo (170 patients), once daily for 48 weeks, almost a year.

Oct 4, 2022 · The trial also met key secondary goals, with lecanemab outperforming placebo at reducing plaque levels and on other measures of disease severity, namely the Alzheimer’s Disease Assessment Scale-cognitive subscale14 (ADAS-cog14), Alzheimer’s Disease Composite Score (ADCOMS) and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS ...

Dec 15, 2023 · While the causes of Alzheimer’s remain incompletely understood, genetics are thought to play a major role in whether or not the disease will develop. In some instances, specific causes of familial Alzheimer’s have been identified. Such was the case for a large family in Columbia, which saw half of its members develop early-onset Alzheimer’s — at a median age of 44 — due to a mutation ...

Apr 21, 2023 · 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 ...