A study from the Barcelona Brain Research Center βeta (BBRC), published in the journal Alzheimer’s & Dementia, confirmed the reliability of the centyloid score as a tool for measuring the amount of amyloid plaques in the brain, a leading indicator of Alzheimer’s disease. These results were important for the approval of this indicator as an official biomarker by the European Medicines Agency.. This is an advance in diagnostic accuracy and the possibility of developing more effective treatments.
The Neuroimaging Research Group of the BBRC, a research center of the Pascual Maragalla Foundation (FPM), in collaboration with the AMYPAD (Amyloid Imaging to Prevent Alzheimer’s Disease) consortium, demonstrated the reliability of this scale for measuring the amount of amyloid plaques, one of the main characteristics of Alzheimer’s disease.. As the FPM explained, the work was carried out in several clinical centers. This increases diagnostic accuracy, especially when assessing doubtful cases..
The first author of the publication and researcher at the center’s neuroimaging research group, Mahnaz Shekari, explained that “The accuracy of the centiloid metric has been demonstrated in patients from memory clinics.”. Establishing it as a reliable biomarker for diagnosing and monitoring Alzheimer’s disease. “In addition, we provide complete and simple guidance on using this indicator for amyloid quantification on PET, making it accessible to both clinical teams and researchers.”
Committee for Medicinal Products for Human Use (CHMP) The EMA has recognized the centiloid unit as a sensitive universal unit of measurement. and reliable analysis of global amyloid load in the brain when used in clinical trials, provided appropriate quality control procedures are followed, they stressed. This allows for consistent comparison of amyloid PET scans between different tracers and procedures. In this way, they support clinical trials for Alzheimer’s disease.
The “Qualification of New Drug Development Methodologies” introduced by the EMA in 2008 certifies the acceptability of innovative development methods, such as new biomarkers, for specific use in research, development or clinical practice. A qualified opinion is issued only if the evidence is considered sufficient to support the intended use of the biomarker. The last such regulation regarding Alzheimer’s disease was adopted in 2013.
“The resolution adopted by the EMA Committee for Medicinal Products for Human Use is an incredible achievement for the team,” said David Valles, director of the centre’s neuroimaging platform and former AMYPAD data manager and researcher. “This support confirms the reliability and applicability of the centiloid method in clinical settings.”which is key given the development of clinical trials and the expected emergence of disease-modifying therapies.”
The results of this The research may benefit more than just clinical groups. They will also be very beneficial for people with Alzheimer’s disease. undergoing pharmacological treatment against amyloid. “Centyloid quantification improves diagnostic accuracy, especially when assessing equivocal cases with intermediate amyloid levels,” says BBRC researcher Juan Domingo Gispert. In these cases, visual assessment can be complex and vary significantly depending on the reader’s experience. “The centiloid score adds predictive value, improves the differential diagnosis of dementia, and is a better predictor of clinical benefit of anti-amyloid therapy,” he insisted.
Given the expected increase in the number of anti-amyloid drugs and their wider clinical use, The centiloid index will be critical to assessing the effectiveness of the drug. and effectively manage dosing. According to the EMA’s qualified opinion, “the use of the centiloid scale could provide a potential benchmark for future monitoring methods or follow-up surveys,” the FPM concluded.
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