Fujirebio Diagnostics has submitted a premarket notification — also known as a 510(k) — to the U.S. Food and Drug Administration (FDA) for its Alzheimer’s diagnostic test, called Lumipulse G β-Amyloid Ratio (1-42/1-40). If cleared by the FDA, it will be among the first commercially available lab tests to…
Biogen and Eisai are seeking approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease in Japan, the companies have announced. If approved, aducanumab will become the first therapy with the potential to slow the clinical decline seen in patients with Alzheimer’s. “The filing of the application is…
Athira Pharma has begun dosing patients in its Phase 2 clinical trial evaluating ATH-1017, an investigational small molecule for the treatment of mild to moderate Alzheimer’s disease. Clinical efficacy will be demonstrated by improvements in cognition and functional assessments among participants, compared with a placebo. “The initiation of…
Cortexyme’s ongoing Phase 2/3 GAIN clinical trial, which is evaluating the investigational treatment COR388 (atuzaginstat) in people with mild to moderate Alzheimer’s disease, has been approved to continue as planned to…
The last participant has completed all predefined assessments in the Phase 3 COGNITE clinical trial, which is assessing the safety and effectiveness of AZTherapies’ treatment candidate ALZT-OP1 for people with early Alzheimer’s disease. The trial’s top-line results are expected in the first months of 2021. The biopharmaceutical…
A recent report found deep social inequalities in U.S. counties with the highest Alzheimer’s rates among Blacks and Latinos. Inequalities related to education, income, food insecurity, and the physical environment are collectively known as social determinants of health and are inextricably tied to location, according to the report from…
A Phase 1 trial is enrolling patients with mild to severe dementia from Alzheimer’s disease to test IGC-AD1, an investigational cannabis-based treatment being developed India Globalization Capital (IGC) Pharma, a subsidiary of IGC, according to a recent press release. In the placebo-controlled study, 12 participants will…
AlzeCure Pharma is preparing to launch a Phase 1 clinical trial in Sweden to evaluate the tolerability and safety of ACD856, one of its therapy candidates for Alzheimer’s disease, the company announced. The trial follows the release of the first positive clinical results, in which ACD856 showed…
Most of the mild to moderate Alzheimer’s patients enrolled in the atuzaginstat (COR388) Phase 2/3 trial show evidence of systemic infection due to Porphyromonas gingivalis, a bacteria linked to periodontal disease whose toxic enzymes are thought to contribute to Alzheimer’s and are targets for this candidate therapy. A “high proportion” also test…
The last participant has completed the planned 24 weeks in the Phase 2 PEGASUS clinical trial, which is assessing the safety and biological activity of Amylyx Pharmaceuticals‘ investigational therapy AMX0035 in people with Alzheimer’s disease. Top-line results from the trial are expected in the first half of…
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