Biomarker risk assignment algorithm diagnostic data
An analysis of 660 patients enrolled in the Alzheimer's Disease Neuroimaging Initiative (ADNI) showed that Takeda's biomarker risk assignment algorithm for predicting onset of MCI due to late-onset AD had a PPV of 79% and an NPV of 44%. The algorithm had 65% sensitivity and 61% specificity. Takeda said the data show the algorithm "compares favorably" with cerebral spinal fluid (CSF) and functional MRI biomarkers recently qualified by EMA. Data were presented at the Alzheimer's Association International Conference in Boston.
Takeda said it will evaluate the biomarker risk assignment algorithm as a predictor of the risk of cognitively normal individuals ages 65-83 developing MCI due to AD in the next 5 years in a Phase III trial, but declined to disclose a time frame for when the trial will start. ...