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Principal Investigator  
Principal Investigator's Name: Kishore Malyavantham
Institution: Quanterix
Department: Accelerator Clinical Lab
Country:
Proposed Analysis: 1. The overall goal of the proposed study is to validate a new version of the Simoa pTau-181 that demonstrates the effectiveness for detecting Alzheimer’s amyloid pathology by comparison to amyloid positron emission tomography (PET) brain images. The clinical validation plan will utilize the baseline set of ADNI-3 cohort consisting of subjects representing different diagnosed diseased states: Cognitively Normal (CN), Mild Cognitive Impairment (MCI) and Alzheimer’s Disease (AD). Sample numbers (UID) and characteristics critical for the study are to be reviewed and identified from this database. Data analysis plan will include calculating Area Under the Curve (AUC) for Receiver-Operator Characteristic (ROC) for the blood-based pTau181 measurements when compared to amyloid status determined from PET imaging. The analysis will evaluate the performance within specific groups, including but not limited to: • AD amyloid positive vs CN amyloid negative • AD amyloid positive vs amyloid negative across all disease states • MCI amyloid positive vs MCI amyloid negative • Amyloid positive across all disease states vs amyloid negative across all disease states 3. Characteristics of Samples requested (table below) for the studies are captured below. ACCESS to the database will allow us (as advised by Prof. Michael Weiner) to make these selections. a. A 0.5 ml sample of EDTA plasma is requested for each subject at baseline of the ADNI-3 study. b. Measurements of biomarkers in CSF: Aβ42, Aβ40 and pTau (subjects in all three categories (CN, MCI and AD) will have had an LP (lumbar puncture). c. For the CN cases requested, longitudinal tracking of conversion to MCI/AD data will be useful for assessing risk of progression. It would be desirable to have 33%-50% of the CN group to have progressed to AD within the monitored period (~5 years). d. For the MCI cases requested, longitudinal tracking of conversion of AD will also be useful for assessing risk of progression. Based on past studies, it is expected that at least 50% will progress to AD over the monitoring period of ~ 5-7 years.
Additional Investigators