SOLICITATION NOTICE
A -- Early Markers of Alzeheimer’s Disease in BLSA Participants: Structural and Functional Brain Changes
- Notice Date
- 11/19/2010
- 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
- HHS-NIH-NIDA(AG)-11-151
- Archive Date
- 1/3/2011
- Point of Contact
- Sara Mclaurin, Phone: 301-443-9154, Craig D. Sager, Phone: 301-443-1193
- E-Mail Address
-
mclaurinsm@mail.nih.gov, csager@mail.nih.gov
(mclaurinsm@mail.nih.gov, csager@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Aging (NIA) intends to issue a solicitation on a sole source basis to Johns Hopkins University, entitled "Early Markers of Alzeheimer's Disease in BLSA Participants: Structural and Functional Brain Changes". The proposed contract action is for R&D services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. 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. Since 1958, the Baltimore Longitudinal Study of Aging (BLSA) has been a major research program conducted at the Gerontology Research Center (GRC) by the National Institute on Aging (NIA). The BLSA is a multi-discplinary study of physiologic and psychologic aspects of normal aging in community-dwelling men and women. Active BLSA participants are volunteers who visit the Intramural Research Program (IRP) in Baltimore, MD for testing every one to five years for 2 days. Since 1994, the program has been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes that may be predictors of cognitive decline and Alzheimer's disease, and to assess the impact of potential modulators of brain and cognitive aging. The work of this contract will focus on the acquisition and analysis of neuroimaging data on BLSA participants. This project will provide important information for researchers and clinicians on age changes in brain structure and function, their associations with cognitive change, and factors that modulate these associations, including risk factors for cognitive decline and Alzheimer's disease. The data to be collected will include assessments of brain structure, function, and amyloid deposition through MR imaging and positron emission tomography (PET) scans, and assessments of memory, other cognitive functions, and mood. Brain structure will be measured using MR volumetric brain imaging, FLAIR or other sequences that are sensitive to vascular abnormalities, and diffusion tensor imaging (DTI). The Contractor shall acquire the neuroimaging scans and shall provide sophisticated quantitative analysis of imaging data, including MR images collected during the initial contract period and new data during the continuation. The Contractor shall employ the refined methods for image analysis developed during the initial contract period, as well as new techniques developed as part of the proposed procurement. The Contractor shall be responsible for quantification of all PET data. The Contractor shall also be responsible for contacting and scheduling the BLSA neuroimaging study participants, arranging transportation where needed, administration and monitoring of procedures during MR and PET imaging, and for administration and scoring of a neuropsychological battery, including assessments of functional status. The Contractor shall also provide a quiet space for neuropsychological testing in close proximity to the imaging facilities that is acceptable to the Project Officer. The Contractor must be located in close proximity to the NIA-IRP to facilitate repeated assessments of this unique population and to allow neuroimaging studies to be conducted in conjunction with regular BLSA visits. Specific Tasks include: Scheduling and Contacting Subjects: The Contractor will be provided with a list of names, telephone numbers, and addresses of eligible BLSA participants and shall be responsible for contacting and scheduling subjects. The Contractor must also provide lunch, parking and travel reimbursements (where necessary) in conjunction with imaging assessments. Brief Medical Evaluation: In conjunction with the imaging assessment, the Contractor shall perform a brief medical screening, including determination of blood pressure and pulse, recording of changes in health history since last BLSA visit, and recording of current medications. Imaging Procedures: State-of-the-art MR and PET image acquisition and analysis procedures are required for the performance of this contract. It is critical to the objectives of this project that comparable image acquisition and analysis procedures are maintained across subjects and years. An attempt shall be made to acquire images on the same scanner for all subjects and over time, where possible. However, it is recognized that over the duration of this contract modifications of the imaging procedures may be necessary to accommodate and take advantage of technical developments. The Contractor must advise the Project Officer of any modifications to the imaging procedures, and the initial and modified procedures must be approved by the Project Officer. Subcontracts of any part of this contract are also subject to the approval of the Project Officer. PET Imaging: The Contractor shall be responsible for all aspects of the PET imaging including preparation and management of any regulatory procedures required prior to and during the conduct of the study. The Contractor should also demonstrate sufficient flexibility to allow modification of PET imaging ligands or procedures to take advantage of new approaches as they are shown to more accurate and more sensitive predictors of cognitive decline and transition to cognitive impairment and dementia. Neuropsychological Testing: The Contractor shall be responsible for administration and scoring of a battery of neuropsychological tests to be given in conjunction with the neuroimaging evaluations. If the neuropsychological battery has been administered within the prior 3 months as part of a regular BLSA visit, the Contractor will not be required to repeat the neuropsychological testing. The neuropsychological battery shall include the following tests in the order specified: Fluent Production (FAS and Animal Naming, Boston Naming Test (Complete Version), WAIS-R Similarities Subtest, California Verbal Learning Test (CVLT), Benton Visual Retention Test (BVRT), Clock Drawing, Blessed Information-Memory-Concentration Test (BIMC), Trails A and B, CVLT Delayed, BVRT Delayed, Card Rotations (Educational Testing Service), Mini-Mental Status Exam. In addition, the Center for Epidemiologic Studies - Depression (CES-D) and the Cognitive Failures Questionnaire (CFQ) shall be administered during participant waiting periods. The Contractor shall be responsible for follow-up assessments, including home visits, of any neuroimaging study participants who no longer return for BLSA and neuroimaging visits. The Project Officer or his designate will work closely with the Contractor, including training, supervision, and routine observations of assessments, to maintain consistency of the neuropsychological evaluations with the BLSA procedures. The Contractor or his designate will report to the Project Officer or his designate on a weekly basis to review BLSA subject participation and any procedural difficulties. Replication, Dissemination or Use of Results. Data will be used by members of the LPC to examine the relation between changes in brain structure and function with normal aging and changes in neuropsychological performance. All data collected under this contract shall be forwarded to the LPC and a copy will be stored at the LPC. Results will be disseminated to the scientific community via presentations at scientific meetings and publications in professional journals. Collaboration of the Contractor principal and co-principal investigators with LPC Investigators in data analyses and reporting of study results will be encouraged. The proposed contractor is uniquely qualified to perform these services for the NIA based on the follwoing considerations: The Johns Hopkins University has provided all the services required to make the Early Markers of Alzheimer's Disease in BLSA Participants: Structural and Functional Brain Changes study fully functional since the initiation of the study. The required services include state-of-the-art volumetric MR and PET-CBF imaging and image processing facilities, including image registration, tissue classification, stereotaxic transformation, regional and voxel-based analysis, as well as network analysis. The Contractor must have the capability to produce short-lived radiopharmaceuticals, including PET 15O-water and 11C- PiB, which require an on-site cyclotron facility. In addition to image acquisition and quantification, the Contractor shall also be responsible for recruitment and scheduling of selected BLSA participants, for administration and scoring of a battery of neuropsychological tests in conjunction with the neuroimaging studies. The Contractor must be located in close proximity to the NIA-IRP to facilitate repeated assessments of this unique population and to allow neuroimaging studies to be conducted in conjunction with regular BLSA visits. Moreover, close proximity is also necessitated by the need for frequent visits to the imaging facility by the Project Officer to monitor the overall project and to ensure compatible procedures for neuropsychological assessments. PET neuroimaging evaluations of BLSA participants are acquired only through this Contract. Johns Hopkins University is the only local facility with the capability of producing the required PET radiopharmaceuticals for human use. This solicitation was previously advertised under sources sought announcement HHS-NIH-NIDA(AG)-RFP-11-151. The anticipated period of performance is three years. Disclaimer and Important notes: This notice does not commit 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. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-11-151/listing.html)
- Place of Performance
- Address: b.Division of Neuroradiology, Department of Radiology, Johns Hopkins Medical Institutions, 600 North Wolfe Street, Baltimore, MD 21205, Baltimore, Maryland, 21205, United States
- Zip Code: 21205
- Zip Code: 21205
- Record
- SN02330661-W 20101121/101119233958-455297cc03ebbf13fb55d9ea550cbfe0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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