Amylyx Pharmaceuticals‘ investigational oral therapy AMX0035 reduces the levels of several biomarkers associated with Alzheimer’s disease, according to an analysis of data from the PEGASUS trial. “The results from this exploratory analysis suggest that AMX0035 engages important pathways implicated in the [development] of Alzheimer’s disease and other neurodegenerative…
Treatment with CT1812, previously called Elayta, slowed the decline of cognitive function among adults with mild to moderate Alzheimer’s disease in a proof-of-concept clinical trial dubbed SHINE. That’s according to results seen after approximately six months of treatment in the Phase 2 SHINE study (NCT03507790) at…
Data from the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) study, the first and largest to focus on people who have early signs of Alzheimer’s disease but are not yet showing symptoms, are now available to researchers around the world. Recognizing a need for starting treatment before any symptoms appear,…
Nearly one year of treatment with blarcamesine (Anavex 2-73), a once-daily oral small molecule being developed by Anavex Life Sciences, slowed cognitive and functional decline in people with early Alzheimer’s disease, according to data from a global Phase 2b/3 clinical study. Researchers also observed that patients on…
The U.S. Food and Drug Administration (FDA) has approved the oral therapy Zunveyl (benzgalantamine), previously known as ALPHA-1062, to treat mild-to-moderate Alzheimer’s disease. “The approval of Zunveyl is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral [Alzheimer’s] treatment…
The use of Montelukast oral film, an experimental therapy being repurposed by Intelgenx to treat mild to moderate Alzheimer’s disease, led to significant improvements in patients’ cognition versus a placebo in a Phase 2 clinical trial. That’s according to the findings of a top-line analysis of efficacy data…
The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,…
Foralumab, an investigational nasal spray being developed by Tiziana Life Sciences, has been cleared by the U.S. Food and Drug Administration (FDA) for expanded use to treat moderate Alzheimer’s disease, and the first patient is expected to be dosed soon. An expanded use program, also called a compassionate…
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly‘s antibody therapy donanemab, now Kisunla, for certain adults with Alzheimer’s disease. 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…
The safety and effectiveness of oral therapy candidate buntanetap are comparable in people with early Alzheimer’s disease regardless of whether they do or do not carry a genetic risk factor known as APOE4. That’s according to new data from a Phase 2/3 clinical trial (NCT05686044) that tested…
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