Biocross announces approval of a clinical study for the identification in blood of markers for the diagnosis of Alzheimer’s disease using a multiparametric test – September 2011

The project, entitled “Identification of markers in blood for multiparametric diagnosis of Alzheimer’s disease”, coordinated by Dr. Javier Rodriguez Olazarán and promoted by Biocross SL., is a multicenter retrospective observational epidemiological study on Alzheimer’s disease. The main objectives are to identify blood markers that enable classification of patients with Alzheimer’s versus healthy subjects and patients with other forms of dementia (frontotemporal, Lewy body, and vascular dementia) with over 85% accuracy, and to analyze the predictive value of markers identified for early diagnosis of the disease in patients with mild cognitive impairment.

This multicenter study involves different centers within the Autonomous Communities of Madrid and Murcia, including the Alzheimer’s Project Research Unit of the Research Center for Neurological Diseases Foundation (FCIEN), Hospital Virgen de la Arrixaca (Murcia), and Hospital La Paz, Hospital Getafe, Hospital Gregorio Maranon, Hospital 12 Octubre, and Hospital Infanta Cristina (Madrid).

The objective is to include over 300 patients, classified as healthy individuals or patients with AD, mild cognitive impairment, or other dementias.

Blood samples collected from participants will be analyzed for APOE alleles, peptide markers associated with lipid metabolism, and related metabolites, including in total 495 ceramides, phospholipids, sphingolipids, triglycerides, diacylglycerols, fatty acids, sterols, and amino acids.

With the support of a group of statisticians from the University of Valladolid, data will be subjected to multivariate analysis (data mining) using multiple algorithms including classification trees, neural networks, and logistic regression. The results of this analysis will be used to generate classification rules based on a limited number of parameters (10–15 variables) that distinguish AD patients from healthy controls and patients with other dementias.