A06r A. Beta-Amyloid Diseases 06r. Imaging & Bio
Post# of 30028
06r. Imaging & Biomarkers: other
20-Mar-2015 00:00 00:00
Abstract: 163
THE LYMPRO® ASSAY: A BIOMARKER FOR ALZHEIMER’S DISEASE USING BLOOD SAMPLES FROM CLINICALLY DIAGNOSED ALZHEIMER’S DISEASE AND COGNITIVELY INTACT SUBJECTS
Objective A blood biomarker would be advantageous for early identification of Alzheimer’s disease (AD). Multiple reports have identified Cell Cycle Dysregulation as a key pathology in AD. Furthermore, it appears likely that this dysfunction is systemic, affecting peripheral blood lymphocytes as well as neurons. This study measures lymphocyte proliferation in response to a mitogenic stimulus to quantify the extent to which lymphocytes have entered the cell division cycle. It potentially represents a blood-based biomarker for AD.
Methods Whole blood samples obtained from 72 subjects (36 AD and 36 age matched controls) were shipped to a reference laboratory (Becton Dickinson) for flow cytometry analysis. Statistical analysis methods included uni- and multivariate receiver-operating curve (ROC) and logistic regression analysis, and calculation of diagnostic performance parameters.
Results Interim analysis demonstrated significant areas under the ROC curve for univariate measures including CD19, CD3+4, CD3+8, CD14, and CD45. These markers were also highly correlated to MMSE scores. On univariate analysis, sensitivity of 66.7% at 83.3% specificity was achieved by the CD3+8 marker. Multivariate model building yielded maximal AUC of 0.871 (odds ratio=24.0) and sensitivity and specificity of 80% and 85.7% at the optimal cutpoint.
Conclusions In this interim analysis, the LymPro assay provides multiple univariate indicators and multivariate combinations, which discriminate AD from controls. The assay appears to be a robust and reproducible measure of a key pathology of AD and the findings corroborate previously published LymPro findings. Final data from the current study will be completed by the time this abstract is presented.
Co-authors
L. Kirby1, P. Jorgensen2, M. Sarno3, C. Bier4.
1Medical Director, Amarantus Bioscience Holdings, San Francisco, USA.
2Laboratory Development Director, Amarantus Bioscience Holdings, San Francisco, USA.
3Statistical analysis, Vision Biotechnology Consulting, San Diego, USA.
4Diagnostics Lead, Amarantus Bioscience Holdings, San Francisco, USA.