D_SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

In vivo efficacy studies of a candidate Alzheimer treatment in a transgenic mouse model

Statement of Need and Purpose:

There is currently a pressing need to identify effective treatments for Alzheimer’s disease (AD).

With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, it is critical to test novel methods of discovering disease-modifying AD treatments. As part of an ongoing study called the Drug Repurposing for Effective Alzheimer’s Medicines (DREAM) study, the NIA IRP is testing whether exposure to commonly prescribed, FDA-approved drugs will be associated with protection against AD. DREAM will test approximately 20 drugs that we have nominated as ‘candidate AD treatments.’ We will select the most promising drugs from the DREAM study that lower AD risk for in vivo efficacy studies in a transgenic mouse model of AD.

Background Information and Objective:

Research in the NIA IRP has identified several FDA approved drugs that may target metabolic abnormalities associated with AD and be of utility as effective disease-modifying treatments.

Repurposing of approved drugs for AD is a promising approach that can accelerate the development of novel AD treatments. As part of the DREAM study, NIA will perform pharmacoepidemiologic analyses of approximately 20 FDA approved drugs to test whether older individuals exposed to these ‘candidate AD treatments’ are at a low lower risk of AD. In parallel with these analyses, NIA will also test whether these drugs ameliorate pathological changes associated with AD at the cellular level. In the next stage of these analyses, NIA propose to select the most promising drug(s) for testing as disease-modifying AD treatments by in vivo efficacy studies in a well-characterized transgenic AD mouse model.

Period of Performance:

September 30, 2021 – September 29, 2022

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:

The main objective of the requirement is but not limited to the following:

1. A ‘best in class’ candidate AD drug will be nominated from ongoing studies including

DREAM as well as from cell culture-based in vitro phenotypic assays being performed at the contractor’s laboratories. These experiments shall be taken forward into in vivo efficacy studies in a transgenic AD mouse model to test whether administration of the drug prior to the emergence of AD pathology results in:

i) improved cognitive performance tested by the Morris Water Maze

ii) reduced amyloid pathology and tau phosphorylation (via brain histology)

iii) reduced amyloid pathology and neuroinflammation (via brain biochemical assays)

iv) reduced neurodegeneration (by serial plasma assays for neurofilament light chain protein (NfL).

Specific Requirements:

LEVEL OF EFFORT:

Senior researcher 960 labor hours for period of performance

GOVERNMENT RESPONSIBILITIES

Nominate a ‘best-in-class’ candidate AD drug for testing in in vivo efficacy studies in a transgenic AD mouse model.

DELIVERY OR DELIVERABLES

Electronic copy of excel spreadsheet including results of the drug phenotypic screening assays and in vivo efficacy studies shall be delivered within 364 calendar days of receipt of the list of ‘candidate AD treatments’ and ‘best-in-class’ candidate AD drug by the contractor. The timely submission of this deliverable is essential to successfully completing this requirement.

REPORTING REQUIREMENTS

The contractor shall provide written progress reports every 2 months for the contract period.

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 should be as follows;

• WORD document detailing all the technical aspects of the experimental methodology used and results of in vivo drug efficacy studies describing its effects on cognitive performance, AD pathology (histology), AD pathology and neuroinflammation (biochemical assays) and neurodegeneration (NfL assay).

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

N/A

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.