A -- Women's Health Initiative Memory Study Extension

The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate on a non-competitive basis with Wake Forest University Health Sciences for a three-year continuation of Contract N01-WH-4-4221 for the Women's Health Initiative Memory Study (WHIMS). Authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1. The WHIMS is an ancillary study to the Women's Health Initiative (WHI) Hormone Therapy (HT) trials. The WHIMS was initially funded by private industry. Beginning in 1996, the WHIMS enrolled 7,145 women aged 65-79 at baseline from the WHI hormone trials to test whether HT prevented cognitive decline, mild cognitive impairment (MCI), and probable dementia (PD, including Alzheimer's disease). After the WHI HT trials were stopped early (in 2002 after 4.0 years of follow-up in the trial of Estrogen plus Progestin [E+P]; in 2004 after 5.2 years of follow-up in the trial of Estrogen-alone [E-Alone]) it was found that E+P doubled the risk of PD, while E-Alone increased by 38% the risk of MCI and PD combined. The current objectives of the WHIMS are to: * Complete WHIMS data collection in the E-Alone trial; * Continue monitoring post-trial cognitive health; * Perform brain MRI scans to elucidate the role of vascular disease, following the finding of an increased stroke risk in the HT trials The NHLBI began funding the WHIMS in December 2003, at which time 4,173 participants were enrolled. The 4.6 year funding period was thought to be sufficient to follow the trajectory of MCI and PD post-trial and to perform brain MRI scans. However, given the findings to date, the increasing population dementia burden, and the need to study its causes using both classic epidemiologic methods and new technologies, we now propose a WHIMS Extension from July 1, 2008 - June 30, 2011 in order to fully leverage this unique resource. The WHIMS Extension objectives are to: * Enhance statistical power necessary to identify predictors of cognitive health and decline by increasing the total number of cases of cognitive impairment and probable dementia by about 40% * Perform repeat brain MRI scans to identify factors related to progression of brain atrophy and lesion volume * Continue assessment of the adverse effects of postmenopausal hormone therapy on cognition * Serve as a national resource on which to build ancillary studies in collaboration with the greater scientific community The current Steering Committee, including WHI investigators, Adjudications Committee, and an External Advisory Board of well qualified experts will continue to manage and advise the study. The WHIMS Extension will fund annual cognitive assessments and those participants who completed the initial MRI substudy in 2006-2007 will be invited back for a repeat MRI. For reasons of minimizing participant burden in an elderly population, administrative efficiency, and cost containment, it's been decided to centralize the data collection within Wake Forest vs. the current method where the field centers collect these data. This will result in a cost reduction of approximately 60% compared with field center interviews. Cognitive data on consenting women will be obtained through telephone interviews by trained and certified staff. The proposed telephone-based protocol has been used successfully in other studies and proven to be a valid and cost-effective method for tracking changes in cognitive status, MCI, and PD. The telephone-based questionnaires closely replicate the results of face-to-face questionnaires currently used in WHIMS and have been validated in other studies. Initial validation studies in WHIMS have confirmed their utility. After a brief hearing screening test, participants will receive the widely-used Telephone Interview for Cognitive Status (TICS) which is modeled after the Modified Mini-Mental Status questionnaire for screening. The Geriatric Depression Scale-Short Form and the WHI Insomnia Rating Scale for sleep disturbance will measure important covariates of cognitive performance. Participants will also report use of cognition-related medications. If a participant's TICS score falls below a cut-point, their pre-designated proxy (next-of-kin, family member, friend) will be contacted by telephone for the administration of the Dementia Questionnaire (DQ). This combination of participant (TICS) and proxy data (DQ) mirrors the current WHIMS protocol and provides data for the adjudication of MCI and PD. In addition, participants will receive the East Boston Memory Test for verbal memory, the Verbal Fluency-Animals test for verbal fluency, and the Digit-Span Test for working memory. As in the current protocol, the telephone-based DQ will continue to be used to determine the dementia status of deceased participants or participants who have ceased full follow-up participation. Wake Forest University and the two existing subcontractors that provide MRI readings and study coordination have the unique capability to provide these required services to the NHLBI for continuation of this study. Inherent duplication of cost to the Government and unacceptable delays in continuing the study make competition unfeasible. It is imperative that the existing logistical structure, the continuity of the study, and the integrity of study data be maintained. Interested respondents must submit, within 45 days of this announcement, a written capability statement demonstrating their ability to perform this research effort on the same study participants. Responses providing insufficient information for evaluation will not be considered. This is not a Request for Proposal. See FedBizOpps Numbered Note 22.