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Experiences from Clinical Research and Routine Use of Florbetaben Amyloid PET-A Decade of Post-Authorization Insights.
Pharmaceuticals (Basel)
December 2024
Life Molecular Imaging GmbH, Tegeler Str. 7, 13353 Berlin, Germany.
Florbetaben (FBB) is a radiopharmaceutical approved by the FDA and EMA in 2014 for the positron emission tomography (PET) imaging of brain amyloid deposition in patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. Initially, the clinical adoption of FBB PET faced significant barriers, including reimbursement challenges and uncertainties regarding its integration into diagnostic clinical practice. This review examines the progress made in overcoming these obstacles and describes the concurrent evolution of the diagnostic landscape.
View Article and Find Full Text PDFAnti-amyloid treatments in Alzheimer's disease: elegance, evidence and ethics.
Adv Clin Exp Med
December 2024
NeuroActiva, Inc., San Jose, USA.
The so-called "amyloid cascade hypothesis" provides an elegant explanation of Alzheimer's disease (AD), has motivated the amyloid-lowering therapeutic strategy, and led to the elaboration of a rich experimental and conceptual toolkit for the field to progress. But it might be incorrect. The scientific evidence base supporting the efficacy and safety of current anti-amyloid antibody treatments in AD is weak.
View Article and Find Full Text PDFArticle Synopsis
- The article reviews the evolution of Alzheimer disease (AD) treatments, highlighting a shift from traditional symptom-oriented therapies to new amyloid-lowering monoclonal antibodies that show potential in slowing disease progression.
- Lecanemab and donanemab are the first amyloid-lowering therapies to receive FDA approval, but they carry risks of serious side effects, necessitating close monitoring through regular MRI scans.
- While acetylcholinesterase inhibitors show strong evidence for improving cognitive function in AD patients, the effectiveness of other behavioral therapies is still uncertain, and the impact of new amyloid treatments on long-term patient outcomes is not yet fully understood.
Amyloid-lowering treatment in Alzheimer's disease.
Lancet
November 2024
Sant Pau Memory Unit, Department of Neurology, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau, Facultad de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain; Center of Biomedical Investigation Network for Neurodegenerative Diseases, Madrid, Spain; Barcelona Down Medical Center, Fundació Catalana de Síndrome de Down, Barcelona, Spain.
The case for regulatory approval of amyloid-lowering immunotherapies in Alzheimer's disease based on clearcut biomarker evidence.
Alzheimers Dement
November 2024
Dpartment of Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Decades of research have provided evidence that Alzheimer's disease (AD) is caused in part by cerebral accumulation of amyloid beta-protein (Aβ). In 2023, the US Food and Drug Administration gave full regulatory approval to a disease-modifying Aβ antibody for early AD. Secondary prevention trials with Aβ antibodies are underway.
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