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Request for Information: Increasing Enrollment in Alzheimers Disease and Related Clinical Trials and Studies

Funding Number: NOT-AG-12-017
Funding Type: NOT
Release Date: November 14, 2012
Expiration Date: January 1, 2019
Web Site: http://grants.nih.gov/grants/guide/notice-files/NOT-AG-12-017.html
Request Information: Increasing Enrollment Alzheimer’s Disease Related Clinical Trials Studies Notice Number: NOT-AG-12-017 Key Dates Release Date: November 14, 2012 Response Date: nbsp;March 15, 2013 Issued National Institute Aging NIA) Purpose National Institute Aging NIA), component the National Institutes Health NIH) the U.S. Department Health Human Services, seeking input U.S.-based international public private organizations sponsoring conducting Alzheimer’s disease other clinical trials studies regarding strategies increasing enrollment Alzheimer’s related clinical trials. Background Alzheimer's disease represents major public health concern.  many 5.1 million Americans estimated have Alzheimer's disease. Further, due the aging the population, number predicted double 2020 triple 2040.  Although few approved drugs alleviate of symptoms Alzheimer's disease, date are treatments available can delay onset slow progression the disease.  light this looming public health crisis, interest Alzheimer’s disease intensifying a growing number countries. first U.S. National Plan Address Alzheimer’s Disease http://aspe.hhs.gov/daltcp/napa/NatlPlan.shtml), released May 2012, as first goal ldquo;Prevent effectively treat Alzheimer’s Disease 2025.” support expanded accelerated research efforts, including clinical trials, needed reach ambitious target, plan also proactively sets action objective ldquo;increase[e] enrollment clinical trials other clinical research through community, national, international outreach.” 1.B.3)  ldquo;Increased enrollment clinical trials crucial the development better treatments ultimately cure AD. Participating clinical trials other research enables volunteers access latest experimental approaches available provides with care clinical research staff. HHS convene representatives across federal government, state local governments, academic medical research institutions, the private sector create action plan increasing enrollment clinical trials, including through building registries. partners identify approaches coordination points these efforts implement action plan.” this Request Information RFI), NIA seeking recommendations actionable strategies increase enrollment clinical trials. Comments sought the following topics: Please describe strategies should more widely adopted enhance participation Alzheimer’s research among people different stages the disease including pre-clinical), normal controls, those a family history, racial ethnic minorities, others. Please indicate support coordination be needed the short-term long-term these efforts. Please indicate most effective role government agencies funders federal, state, local) support facilitate coordination Alzheimer’s clinical trial recruitment efforts. Please describe registries be used support Alzheimer’s related clinical trials studies. Please discuss whether is need a centralized registry how existing registries tools might coordinated used most effectively. Submitting Response U.S.-based international public private organizations sponsoring conducting Alzheimer’s disease other clinical trials studies, are interested advising effort should send responses the NIA using contact information below.  Responding this RFI not considered a commitment participate the development implementation the action plan.  Responses be publicly available.  RFI for information planning purposes only should be construed a solicitation as obligation the part the Federal Government, NIH, and/or National Institute Aging.  NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government’s of such information. Please respond March 15, 2013 mark responses the RFI identifier NOT-AG-12-017 responding via email. Inquiries Please direct inquiries to: Jennifer L. Watson, Senior Public Affairs Specialist National Institute Aging NIA) 31 Center Drive, Room 5C27 Bethesda, MD 20892-2292 Phone: 301-496-1752 Email: watsonjl@nia.nih.gov Website: www.nia.nih.gov/alzheimers