BLSA_Metabolomic_SOW_FINAL.doc

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Metabolomic Signature Underlying Motor and Cognitive Dual Decline in the Baltimore Longitudinal Study of Aging Statement of Need and Purpose:

The purpose of this requirement is perform metablomic assays on plasma samples collected from the Baltimore Longitudinal Study of Aging (BLSA) to examine the metabolomic signature underlying motor and cognitive dual decline and examine its relationship with subsequent mild cognitive impairment and Alzheimer’s disease.

Background Information and Objective:

Alzheimer’s disease (AD) is characterized by a progressive decline in memory and other impaired cognitive abilities ultimately affecting daily function. One of the earliest behavioral manifestations of AD includes poor performance in non-cognitive domains, such as slow gait1

, but whether all individuals who develop AD experience gait decline before developing the cognitive outcome is little understood. Previous metabolomics studies suggest that metabolic dysregulation may be a sensitive, early marker of AD. We hypothesize that individuals who develop both cognitive and mobility problems in the clinical course to dementia represent a specific subgroup that develop AD, and they may be characterized by specific metabolic disorders that affect brain health and other aspects that negatively affect mobility.

The main goals of this proposal are 1) to identify phenotypic groups using preclinical motor and cognitive trajectories, and 2) to examine underlying metabolic profiles of motor- and cognitive-dual decliners that distinguish them from others. Our long-term goal is to extend early preclinical identification of high-risk individuals using a combination of early behavioral phenotypes and inexpensive biomarkers.

Period of Performance:

The period of performance for this contract will be one year beginning on/about 7/1/19 – 6/30/20.

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:

The Contractor shall –

Perform metabolomic assays on 3021 human plasma samples collected in the BLSA, generate and report data.

LEVEL OF EFFORT:

A team of researchers required to complete plasma metabolomic assays and quality control (QC).

GOVERNMENT RESPONSIBILITIES

The government shall provide adequate quantities of archived plasma samples to the contractor to enable the performance of the metabolomic assay detailed above.

DELIVERY OR DELIVERABLES

The contractor shall provide an electronic copy of spreadsheet or database files incuding raw assay data and quantitative measurements of metabolites. The contractor shall also provide written documentation to describe any quality control and process of the data generated along with the codes that were used to conduct each of the QC and processing procedure.

REPORTING REQUIREMENTS

The contractor shall submit via e-mail as PDF or a MS Word document a progress reports every month during the contract period. The progress report shall include tasks completed since submission of the last progress report and a list of tasks to be completed, inclusive of timeframe. This report shall also describe any problems that arose and state the resolution or provide an explanation if a solution was not identified.

OTHER CONSIDERATIONS

Travel:

N/A Key Personnel:

The key personnel requirements for the senior researcher are as follows:

· A Masters or PhD in a laboratory science field

· Extensive experience in high throughput lab methods.

Information System Security Plan:

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.

Section 508—Electronic and Information Technology Standards:

The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW.

Publications and Publicity:

Confidentiality of Information:

The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.

Statement of Work, May 2019