SOLICITATION NOTICE
A -- RECOVERY – Action to Control Cardiovascular Risk in Diabetes – Memory in Diabetes Magnetic Resonance Imaging Follow-up Study (MIND-MRI-FUP).
- Notice Date
- 4/2/2010
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- NIH-AG-2010-124
- Archive Date
- 5/4/2010
- Point of Contact
- Suzanne Stinson, Phone: 301 443 4116, Sara Mclaurin, Phone: 301-443-9154
- E-Mail Address
-
sstinson@mail.nih.gov, mclaurinsm@mail.nih.gov
(sstinson@mail.nih.gov, mclaurinsm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Aging (NIA)/NIH intends to negotiate, under authority of FAR 6.302-1, on a non-competitive, sole source basis, with Wake Forest University, Sticht Center on Aging - Center for Diabetes Research, hereinafter referred to as the Coordinating Center, for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) - Memory in Diabetes (MIND) Study for the MIND-FUP Study. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within fifteen days after date of publication of this synopsis will be considered by the government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. ACCORD-MIND included a sub-set of ACCORD trial patients who participated in cognitive testing (n=2977) and Magnetic Resonance Imaging (MRI) of the brain (n=620). This effort will be a two-year follow-up of the ACCORD-MIND MRI component of the clinical trial, which is in accordance with the authority 41 U.S.C. 252(c)(1), as set forth in FAR 6.302-1. The contractor has been involved in the recruitment, treatment strategies and clinical visits, follow-up of the participants, and collection of data on the ACCORD-MIND MRI participants from four communities across the United States. The incumbent contractor has the unique capability to provide these required services to NIA for the study follow-up. Inherent duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this study. The objectives of the study are detailed below. Background and Purpose of the ACCORD-MIND Trial: About 24 million people (almost 8% of the U.S. population) have diabetes. Older persons with diabetes have an increased risk for cognitive impairment and two times higher risk for dementia compared to older persons with no diabetes. Diabetes is also frequently co-morbid with other cardiovascular risk factors, such as hypertension, which are factors also known to increase the risk for cognitive impairment and dementia. Underlying this functional impairment are pathologic structural changes in the brain that can be imaged with Magnetic Resonance Image (MRI) technology. ACCORD-MIND MRI is a sub-study in ACCORD, which is a randomized, multicenter, factorial designed clinical trial in 10,251 participants with type 2 diabetes mellitus. MIND MRI included 620 of these participants, and was conducted at four sites, and managed through a central coordinating office and four clinical networks. The coordinating center includes a central MRI quality control and reading center. The goal of the ACCORD-MIND trial was to address the question as to whether three complimentary treatment strategies could reduce the risk for cognitive decline or adverse changes in brain structure. The treatment strategies were designed to control glycemia to near-normal levels (target HbA1c < 6%) of fibrates, to increase HDL-cholesterol and lower triglycerides in the context of good LDL-C control by statins, and of intensive BP control targeting the normal range (SBP< 120 mmHg). Specifically, ACCORD-MIND evaluates intensive glucose, blood pressure and lipid management as means to reduce detrimental changes in the brain structure and function. ACCORD MIND MRI Follow-Up Study Objectives: The two-year observational MIND-MRI-FUP Study is anticipated to begin September 2010 and continue to September 2012. This document describes a follow-up to the MIND-MRI sub-study participants, implemented in the context of the overall main ACCORD Follow-up Study through NHLBI. During the follow-up study, all ACCORD-MIND MRI participants would be invited to provide informed consent for another MRI and to have the scan performed. Based upon data collected at the 40-month MIND MRI exam, an estimated 85% of the original 620 participants is anticipated to be available for this additional MRI. The goals of follow-up data collection are to obtain key imaging data, to estimate trajectories of structural brain change, and to identify factors that reduce or increase the risk for brain structure damage. Therefore, the follow-up data must be comparable to those obtained during the previous ACCORD-MIND MRI sub-study. Additionally, the follow-up of the MIND participants can provide unique data to develop guidelines for clinical management of older persons with diabetes and to give insight into the pathophysiology of diabetes in the brain. The follow-up phase would consist of one MRI visit. Recruitment for the MRI will be done simultaneously with the follow-up clinic visits proposed for the main trial follow-up study. Clinic sites would use streamlined approaches from the current methods to obtain consent and to schedule the patient for an MRI. The MRI acquisition protocol, alert system, transmission to the QC center, quality checks and evaluation will follow the same protocol as was used in ACCORD-MIND. The Coordinating Center's responsibilities include but are not limited to: continue all data collection and analysis including the documentation and maintenance of appropriate confidentiality and security of these files for the sub-study; assist in the implementation of the protocol and manuals of procedures; monitor the regulatory aspects of the study; establish standardized quality of data gathering; maintain quality control and monitoring of the performance status of the MRI sites; and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government (four quarterly reports and a final report). The contract will require an extensive comparison of the MIND-FUP Study data to previously collected MIND data. This proposed acquisition was previously advertised under sources sought announcements HHS-NIH-NIDA(AG)-SBSS-10-124 and HHS-NIH-NIDA(AG)-RDSS-10-124. This notice of intent will be issued on or about April 2, 2010, and will close on or about April 19, 2010. The estimated award date will be September 2010.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/NIH-AG-2010-124/listing.html)
- Record
- SN02111931-W 20100404/100402235824-b98a277426aa8f03f2c44e2c8df37252 (fbodaily.com)
- Source
-
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