This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

GENERAL INFORMATION
Title of Project: Brain and blood metabolite signatures of pathology and progression in
Alzheimer's disease

Statement of Need and Purpose:
There is currently a pressing need to identify predictive blood-based biomarkers of Alzheimer's disease (AD). With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, the emerging paradigm shift in Alzheimer's research calls for disease-modifying treatments to be initiated in older individuals who are in preclinical stages of disease i.e. prior to the onset of overt cognitive decline1. However, this raises the critical challenge of accurately identifying such at-risk individuals by non- invasive and inexpensive methods. If available, such methods will allow for the effective screening of large numbers of vulnerable individuals for recruitment into clinical trials and rapid testing of promising disease-modifying treatments.

Background Information and Objective:
Currently the only modalities that are available for this purpose are assays of cerebrospinal fluid (CSF) markers of Aβ42 and tau (total and phosphorylated) and neuroimaging methods that quantify brain atrophy or fibrillar amyloid deposition. It is however unlikely that lumbar puncture (LP) will be routinely performed in large numbers of frail elderly individuals as it is associated with a degree of discomfort. Furthermore, it is impractical to perform serial LPs in an individual to monitor a biomarker response to treatment. On the other hand, neuroimaging methods are expensive and not readily available in resource-poor settings. We have therefore focused on blood-based biomarkers of AD that accurately reflect well-established endophenotypes of AD pathology such as brain atrophy, and in vivo fibrillar Aβ deposition4-8. Using mass spectrometry-based proteomic analyses in combination with multi-modal neuroimaging, these studies have revealed a robust peripheral signal from the plasma proteome that appears to be associated with AD pathology.

Period of Performance:
September 30, 2017 - September 29, 2018

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 vendor shall:
1. Perform quantitative targeted metabolomics assays on approximately 150 brain tissue and 112 human serum samples from non-demented older individuals and converters to AD to measure the concentrations of small metabolites in the following classes:
i) Amino Acids, Acylcarnitines, Lipids, Hexoses, Biogenic Amines & Polyamines.
ii) Phosphatidylserines
iii) Phosphatidylglycerols
iv) Phosphatidyethanolamines
v) Ceramides
vi) Free oxysterols
vii) Free fatty acids
viii) Bile acids
2. Perform statistical analysis (accuracy, sensitivity, specificity) to identify small metabolite markers in brain that are associated with AD pathology and in serum that predict incident AD.
3. Return all unused specimens to their place of origin.

LEVEL OF EFFORT:
Senior Researcher

GOVERNMENT RESPONSIBILITIES
Provide adequate quantities of archived serum and brain tissue samples to the contractor to enable the performance of the metabolomics assays detailed above.

DELIVERY OR DELIVERABLES
Electronic copy of excel spreadsheet incuding abolsute concentrations of all assayed metabolites in brain and blood samples to be delivered within 364 calendar says of receipt of samples by the contractor. The timely submission of this deliverable is essential to successful completing this requirement.

REPORTING REQUIREMENTS
The contractor is required to provide written progress reports every 2 months for the contract period 9/30/17 through 9/29/18. The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation.

Reports are required as follows:

1. Excel spreadsheet with absolute serum and brain tissue concentrations for metabolites listed above on all serum and brain samples provided to the contractor

2. WORD document detailing all the technical aspects of the experimental methodology used including coefficients of variation (CV) of the assays, specimen usage, and success/failure rate of the assay

3. WORD document summarizing the clinical utility measures of the best serum and brain metabolite markers associated with AD

OTHER CONSIDERATIONS
Travel:
N/A

Key Personnel:
Senior Researcher

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." 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:
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.

Capability statement /information sought. Capability statement /information sought. Contractors that believe they possess the ability to provide the requirement should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The response should directly and specifically state in the, capabilities statement, which project requirements you can supply. Contractors must also provide their Company Name, DUNS Number, Physical Address, Point of Contact, and Size and Type of Business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

The information submitted must be must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

All responses (capability statements) sent in response to this Sources Sought Notice must be submitted electronically (via e-mail) to the Contract Specialist. Facsimile responses are NOT accepted.

The response must be submitted to Stacey Polk, Contract Specialist at [email protected].

The response must be received on or before the response due date provided in this notice.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).