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Fujirebio Diagnostics asked the U.S. Food and Drug Administration (FDA) to approve its Alzheimer’s disease diagnostic blood test,  Lumipulse G pTau 217/β [beta]-Amyloid 1-42 Plasma Ratio. If approved, the test would be the first commercially available blood-based in vitro test in the U.S. to aid in diagnosing…

Alzamend Neuro is partnering with Massachusetts General Hospital to conduct a Phase 2 clinical trial of AL001, an oral therapy being developed for dementia related to Alzheimer’s disease. The trial will compare the brain levels of AL001, a novel lithium-delivery system, with those of marketed lithium, in healthy…

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…