Biocross is involved in a new multicenter study in which 17 hospitals from Spain, France, and Belgium are participating. The objective is to recruit over 500 patients, classified as healthy individuals or patients with AD, mild cognitive impairment, or other dementias.
In a preliminary multicenter clinical study completed in March 2013 and involving 7 Spanish hospitals, Biocross collected 306 samples from healthy controls and patients with AD and other types of dementia. This study evaluated the sensitivity, specificity, and precision of the components of a new diagnostic blood test.
After all the data were collected, ROC curves were generated for the key variables as well as the combinations for each model. The combined multiparametric approximation allows the distinction of AD patients from healthy controls with 85% precision, and from patients with other types of dementia with 83% precision.
The new diagnostic criteria for AD and MCI (NIA-AA, Alzheimer’s and Dementia, 2011) propose the use of diagnostic classification algorithms that combine clinical information with information provided by AD biomarkers. The proposed biomarkers are CSF analysis and/or imaging tests (MR or PET).
At Biocross, we believe that a biomarker panel consisting of distinct blood marker types can effectively serve as the basis for a classification rule to be used for the diagnosis of AD, with a level of accuracy comparable to that of current CSF markers.
Based on this proposal, Biocross will participate in a new study to validate a multiparametric diagnostic blood test for the diagnosis of Alzheimer’s disease. The new multiparametric blood test developed by Biocross will be demonstrated to be of comparable accuracy to currently used CSF analyses (β-amyloid, Tau, and p-Tau), and will be combined with diagnostic algorithms to ultimately replace CSF analysis.
The purpose of this study is to validate, in a well-characterized population, a new, multiparametric diagnostic test that is based on new AD diagnostic criteria and combines distinct biomarker types, selected based on prior exploratory studies carried out by Biocross.
