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FBO DAILY ISSUE OF JUNE 12, 2010 FBO #3122
SOLICITATION NOTICE

A -- Hormone Therapy and Cognitive Aging in Older and Younger Postmenopausal Women: Continuation Study of WHIMS-ECHO and WHIMS-Y

Notice Date

6/10/2010
 

Notice Type

Presolicitation
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Room 260 - MSC 8402, Bethesda, Maryland, 20892
 

ZIP Code

20892
 

Solicitation Number

HHS-NIH-NIDA(AG)-RFP-10-127
 

Point of Contact

Sara M. McLaurin, Phone: 3014439154
 

E-Mail Address

mclaurinsm@nida.nih.gov
(mclaurinsm@nida.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

Hormone Therapy and Cognitive Aging in Older and Younger post-Menopausal Women HHS-NIH-NIDA(AG)-RFP-10-127 The National Institute of Aging (NIA) intends to issue a solicitation on a sole source basis to Wake Forest University, entitled "Hormone Therapy and Cognitive Aging in Older and Younger Post-Menopausal Women: Extension Study of WHIMS-ECHO and WHIMS-Y". 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. Background: The Women's Health Initiative (WHI) randomized clinical trials of hormone therapy (HT) were designed to determine whether HT had beneficial effects on health outcomes, especially cardiovascular health, in postmenopausal women. Women without uteri were randomly assigned to take one daily tablet containing either conjugated equine estrogens (CEE), 0.625 mg (Premarin, Wyeth Pharmaceuticals), or a matching placebo (also provided by Wyeth Pharmaceuticals), and women with uteri were randomly assigned to take one daily tablet containing either CEE, 0.625 mg, and medroxyprogesterone acetate (MPA), 2.5 mg, (Prempro, Wyeth Pharmaceuticals) or a matching placebo (also provided by Wyeth Pharmaceuticals). The WHI Memory Study (WHIMS) was an ancillary study (conducted with private funding) to the WHI and investigated the effects of CEE-containing HT on risk of probable dementia and any cognitive impairment and on changes in global cognition over time. WHIMS included 7,450 WHI participants enrolled at 39 of the 40 WHI clinical sites who were age 65 and older. Because WHIMS did not include detailed cognitive assessments of women without cognitive impairment, the WHI Study of Cognitive Aging (WHISCA) was designed as an ancillary study to WHIMS to assess memory and other domain-specific cognitive functions in women free of dementia. WHISCA included 2,305 WHIMS participants at 14 clinical sites and was conducted under contract number N01-AG-9-2115. The WHI and ancillary WHIMS and WHISCA studies were stopped earlier than planned for both the combination therapy (CEE+MPA in 2002) and CEE-Alone (in 2004) because these treatments increased health risks and did not protect against coronary heart disease. Although study medications were discontinued, follow-up assessments continued in WHIMS and WHISCA as well as the main WHI trials. WHIMS and WHISCA were designed to test the hypothesis, suggested by results of observational studies, that HT had beneficial effects on maintenance of cognitive health in older post-menopausal women, reducing the risk for dementia and protecting against age-associated memory loss. Contrary to expectations, WHIMS showed that HT increased the risk for probable dementia and was associated with poorer global cognition, and WHISCA showed that CEE+MPA treatment was associated with poorer verbal memory over time and that CEE-Alone did not improve verbal memory. The WHIMS and WHISCA protocols have transitioned from face-to-face to less costly and more efficient centrally based and validated telephone interviews to assess cognitive functioning. The WHIMS Epidemiology of Cognitive Health Outcomes (WHIMS-ECHO) continues through 2010 as part of the current WHI extension follow-up (N01-WH-4-4221) and includes assessments previously performed through WHIMS and WHISCA evaluations. Up to 3,900 women are expected to participate in the WHIMS-ECHO study. In addition, the new, Women's Health Initiative Memory Study of Younger Women (WHIMS-Y), is underway, also funded under N01-WH-4-4221. In this study, the telephone-based WHIMS ECHO protocol is used to assess the long-term impact of random assignment to postmenopausal hormone therapy among women who were 50-54 years of age at the time they were initially enrolled into the WHI hormone trials. Hormone therapy continues to be widely prescribed for the treatment of menopausal symptoms. Further, there remains a strong belief among basic and clinical scientists that HT begun during the peri- or immediate post-menopausal periods may bestow cognitive benefits and that the cognitive harm associated with HT in the post-menopausal woman occurs only when there is some pre-existing, sub-clinical disease and/or the aging brain is more vulnerable to the possible negative effects of hormones. WHIMS-Y takes advantage of the rich WHI cohort by adding critical information on the clinical treatment of peri-menopausal and early post-menopausal women and on potential mechanisms of action for how HT may affect cognition. Thus, by the end of the current WHIMS extension period (N01-WH-4-4221), cognitive data will be available for a large portion of the women who participated in the WHI HT, with longitudinal cognitive data on the women who were 65 and older at the beginning of WHI as well as an initial and follow-up assessment for women who were 50-54 at baseline. The proposed extension of WHIMS-ECHO and WHIMS-Y offers a unique opportunity to gain further insights into the antecedents of cognitive decline or stability, and further clarify the contributions of vascular disease in dementia. The ability to advance science by a systematic study of the predictors of decline or stability of cognitive health will be greatly enhanced by longer follow-up for up to 19 years. As the participants grow older, the proportion with cognitive impairment or dementia is expected to increase rapidly. Feasibility and cost will be explored with the offeror during negotiations. PURPOSE AND OBJECTIVES There are 2 objectives of this contract: Objective 1 - Continued surveillance of the WHIMS-ECHO cohort. The purpose of this objective is to investigate the long-term effects of HT on dementia risk and cognitive function in older postmenopausal women. This includes: a) Enhance statistical power to identify predictors of cognitive decline and cognitive resilience.; b) Continue assessment of the adverse effects of postmenopausal hormone therapy on cognition as these women pass through the risk period for accelerated cognitive decline and impairment; and, c) Continue to serve as a national resource on which to build ancillary studies in collaboration with the greater scientific community. Objective 2 - Continued surveillance of the WHIMS-Y cohort. The purpose of this objective is to investigate the long-term effects of early treatment with HT on cognitive health. This includes: a) To determine the later impact of HT when administered to younger, more recently menopausal women; b) To determine whether these effects differ from the adverse effects observed in older postmenopausal women; and, c) To investigate mid-life predictors of cognitive decline and resilience. The proposed contractor is uniquely qualified to perform these services for the NIA based on the following considerations: WHIMS, an ancillary study to the WHI, began as a privately funded study to investigate the effects of hormone therapy on risk for dementia and cognitive impairment within the context of the WHI clinical trials of hormone therapy. More recently, under an NHLBI contract, the proposed Contractor expanded these studies to include an MRI assessment of WHIMS participants (WHIMS-MRI) and to evaluate WHI participants who were randomized to hormone therapy between the ages of 50 and 54 years (WHIMS-Y). The proposed contract will provide continued surveillance of WHIMS participants to investigate long-term effects of hormone therapy on dementia risk and cognitive decline and will provide continued surveillance of WHIMS-Y participants to investigate long-term effects of hormone therapy in women exposed during early menopause. The proposed Contractor is uniquely qualified to conduct these studies as the WHIMS study began at Wake Forest University with private funding and the Contractor has developed and maintained the cohorts and procedures in the initial assessment periods. This solicitation was previously advertised under sources sought announcements #HHS-NIH-NIDA(AG)-RDSS-10-127 and HHS-NIH-NIDA(AG)-SBSS-10-127. Anticipated Period of Performance: The anticipated period of performance is 5 years. 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. 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). Government Point of Contact Sara McLaurin Contract Specialist, NIDA Neuroscience COAC NIA R&D Contracts Management Branch 6001 Executive Blvd., Rm. 8154 (MSC 9661) Bethesda, MD 20892 [For commercial overnight services use: Rockville, MD 20852] Voice: 301-443-9154 Fax: 301-443-0501 E-mail: mclaurinsm@nida.nih.gov Collect calls will not be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA(AG)-RFP-10-127/listing.html)
 

Place of Performance

Address: Wake Forest University School of Medicine, Winston Salem, North Carolina, 27157, United States

Zip Code: 27157
 

Record

SN02173958-W 20100612/100610234938-a79f68f9b7407da6e357bf46ab34cc55 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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