Blood Amyloid-β Oligomerization as a Biomarker of Alzheimer's Disease: A Blinded Validation Study.

Background: Oligomeric amyloid-β (Aβ) is one of the major contributors to the pathomechanism of Alzheimer's disease (AD); Aβ oligomerization in plasma can be measured using a Multimer Detection System-Oligomeric Aβ (MDS-OAβ) after incubation with spiked synthetic Aβ.

Objective: We evaluated the clinical sensitivity and specificity of the MDS-OAβ values for prediction of AD.

Methods: The MDS-OAβ values measured using inBlood™ OAβ test in heparin-treated plasma samples from 52 AD patients in comparison with 52 community-based subjects with normal cognition (NC). The inclusion criterion was proposed by the NINCDS-ADRDA and additionally required at least 6 months of follow-up from the initial clinical diagnosis in the course of AD.

Results: The MDS-OAβ values were 1.43±0.30 ng/ml in AD and 0.45±0.19 (p < 0.001) in NC, respectively. Using a cut-off value of 0.78 ng/ml, the results revealed 100% sensitivity and 92.31% specificity.

Conclusion: MDS-OAβ to measure plasma Aβ oligomerization is a valuable blood-based biomarker for clinical diagnosis of AD, with high sensitivity and specificity.