Attachment-Statement of Work - 75N95022Q00330.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

High Precision Mass Spectrometry Assays to Track the Temporal Progression of Plasma AD Biomarkers in BLSA PET Participants Statement of Need and Purpose:

The National Institute on Aging (NIA) has followed selected Baltimore Longitudinal Study of Aging (BLSA) participants using PET scanning to track the progression of amyloid and tau in the brain. Measures of plasma biomarkers of AD pathology and neurodegeneration have also recently been performed using Simoa assays to track AB40, AB42, GFAP, NF-Light, and pTau 181 in samples concurrent with PET imaging assessments. Preliminary results suggest that changes in some biomarkers have already occurred prior to the first PET scan studies. Further, a recent head to head comparison was published demonstrating the superiority of mass spectrometry versus Simoa assays in predicting brain amyloid measured by PET. Thus, this procurement is to perform high precision mass spectrometry assays of plams biomarkers, prior to and concurrent with PET amyloid and tau assessments.

Background Information and Objective:

In a selected subsample of BLSA participants, brain amyloid and tau have been measured to track the temporal progression of AD pathology in relation to neurodegeneration, cognitive decline and impairment. Since 2005, PET-PiB (Pittsburgh Compound B) has been used to measure brain amyloid in more than 200 participants (~700 visits), and since 2016, 18-F- Flortaucipir (AV-1451) has been used to measure regional distribution of brain tau. More recently, plasma biomarkers of AD pathology and neurodegeneration from stored BLSA samples have been evaluated for visits concurrent with PET studies. These include AB40, AB42, GFAP, NF-Light, and pTau 181, measured using Simoa assays. As noted above, preliminary results of these plasma biomarker studies suggest that some changes in biomarkers may occur before our first PET assessment. Further, recent studies have demonstrated higher concordance of high precision mass spectrometry compared to Simoa assays with measures of brain amyloid by PET.

Thus, the purpose of the proposed acquision is two-fold:

• To obtain high precision mass spectrometry measures of plasma biomarkers of amyloid and tau in participants who have received brain PET scans of amyloid and/or tau.

• To extend these high precision mass spectrometry measures of plasma amyloid and tau in PET participants, by including plasma samples prior to the first PET scan study. Stored samples are available for these participants as many as 10 to 20 years prior to the first PET amyloid scan.

This procurement will provide critical information and unique insights into the temporal progression of plasma biomarkers of AD and neuropathology in relation to PET amyloid, tau, neurodegeneration and cognitive change given the availability of BLSA plasma samples many years prior to PET scanning. New insights may lead to novel treatments to help prevent or delay AD.

Period of Performance:

09/01/2022 to 08/31/2023

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

Contractor shall provide high precision LC-MS plasma measures of amyloid beta 42/40 ratio and ptau from 680 plasma samples from BLSA participants.

GOVERNMENT RESPONSIBILITIES

The government will provide the serum/plasma samples to be assayed.

DELIVERY OR DELIVERABLES

The contractor shall deliver an electronic copy of the results of the analysis within 1 year from the date of receipt of the contract.

REPORTING REQUIREMENTS

The contractor is required to provide a written progress report once the samples have been analyzed that will cover measurements for each sample, problems encountered, problem resolution, and unresolved problems.

Key Personnel:

Dr. Randall Bateman Samples to be performed in the laboratory of Dr. Bateman at Washington University.

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.

Publications and Publicity:

The contractor will work with the National Institute on Aging on publications. Any publications are required to follow the NIA.