D_SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Predicting cognitive decline across the Alzheimer’s disease spectrum using plasma proteomics

Statement of Need and Purpose:

The purpose of this requirement is to utilize a discovery-based proteomics platform in archived plasma samples collected in the Baltimore Longitudinal Study of Aging (BLSA) to identify circulating molecules and molecular pathways that accelerate cognitive decline, particularly in individuals at risk for Alzheimer’s disease (AD). The National Institute on Aging (NIA) will combine this data with data previously analyzed with SomaLogic technology. Discovery-based proteomics will also be used to examine the proteomic signature of non-AD neurodegenerative and neuroinflammatory conditions using banked specimens from other existing cohorts.

Background Information and Objective:

Alzheimer’s disease (AD) is a neurodegenerative condition characterized by progressive cognitive and functional decline as well as tau-containing neurofibrillary tangles and amyloid beta (Aβ) deposits. Currently, no effective interventions exist to slow or stop the progression of AD. Several biomarkers have been widely used to capture AD pathology in vivo, including fluid and neuroimaging biomarkers of Aβ and tau, whereas lesser explored biomarkers such as glial fibrillary acidic protein (GFAP) are rapidly gaining support for their utility in the context of AD. Aβ and tau have been at the center of AD research for decades, and it is now understood that these two features do not fully explain the emergence and progression of cognitive decline and other clinical symptoms in the context of AD. Thus, an improved understanding of the biological processes that regulate cognitive decline across the AD continuum is warranted.

Using plasma specimens from the Baltimore Longitudinal Study of Aging (BLSA), the present requirement aims to identify a set of plasma proteins associated with cognitive decline in individuals with preclinical/prodromal AD. This approach will use available plasma biomarkers of brain amyloid accumulation (Aβ42/40) and tau phosphorylation (p-tau181) to identify a subset of non-demented older adults with preclinical/prodromal AD. Within this participant subgroup, NIA will identify individual plasma proteins and protein combinations that are associated with future cognitive decline. NIA will conduct a parallel analysis in non-demented individuals with biomarker evidence of absent or minimal AD pathology, allowing NIA to contrast the identified protein sets, and use pathway analyses to understand how the biological processes associated with cognitive decline differ based on the presence (or level) of AD pathology. NIA expects that this analysis will yield a novel set of plasma protein panels that can be used to identify individuals at greatest risk cognitive decline in the coming years. Discovery-based proteomics will also be used examine the proteomic signature of non-AD neurodegenerative and neuroinflammatory conditions (e.g., multiple sclerosis) using banked specimens from existing cohorts. This multi-etiology comparison will further enhance NIA’s ability to identify disease-common and disease-specific biomarkers. NIA will combine the results of the 7,000 assays performed in this analysis with the results previously derived from other samples.

Period of Performance:

The period of performance for this contract will be 6 months of receipt of samples.

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 discovery-based proteomic assays on approximately 850 human plasma samples to identify molecular pathways that accelerate cognitive decline. The contractor shall use the aptamer-based assay to measure levels of approximately 7,000 proteins including cytokines, growth factors, receptors, proteases, protease inhibitors, kinases, structural proteins, and hormones known to be important in human diseases. The assay should require approximately 100 microliters of plasma or serum and allow hundreds of assays to be run in a parallel 96-well plates. The contractor shall use a modified aptamer-based reagent comprised of synthetic single-stranded DNA sequences with protein-like appendages that bind to specific target proteins. The single-stranded DNA SOMAmer reagent should then be quantifiable by hybridization to a custom DNA microarray containing probes complementary to the SOMAmer sequences.

LEVEL OF EFFORT:

Senior researcher or technical researcher.

GOVERNMENT RESPONSIBILITIES

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

DELIVERY OR DELIVERABLES

The contractor shall provide an electronic copy of spreadsheet or database files including quantitative measurement of all proteins assayed in the provided plasma samples and relevant quality control metrics (including specimen usage, assay coefficients of variation, assay success/failure rates, normalization process) as well as an electronic copy of a report summarizing the laboratory methods and technical specifications used, both to be delivered within 6 months of receipt of the samples by the contractor.

REPORTING REQUIREMENTS

The contractor shall submit via e-mail as PDF or a MS Word document a progress report during the contract period. The progress report shall include tasks completed 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:

N/A

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.”

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:

N/A

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.