View item

US National Institutes of Health Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required) – PAR-18-878
Sponsor: US National Institutes of Health 		Closing Date: 05-Feb-2019
This Funding Opportunity Announcement (FOA) encourages R01 grant applications that propose to develop and implement late stage (Phase II/III, III) clinical trials of promising pharmacological and non-pharmacological interventions in individuals with age-related cognitive decline and across the Alzheimer's disease (AD) spectrum from pre-symptomatic to more severe stages of disease.

This funding opportunity will support Phase III clinical trials testing pharmacological (small molecules and biologics) and non-pharmacological interventions, using a combination of biomarkers (fluid and imaging), cognitive, and functional measures as outcomes. These applications may include trials testing combinations of interventions that may act synergistically to produce a more robust and long-lasting response, as well as combinations of interventions that attempt to address multiple risk factors simultaneously (e.g., obesity, hypertension, diabetes, physical inactivity, anxiety, and depression). Investigators will be expected to collect DNA and other biosamples from these studies to enable subsequent interrogation of treatment responsiveness, as well as examination of predictors of decline in the groups receiving placebo.

Phase III clinical trial applications that are appropriate for this FOA will have established proof of mechanism or target engagement at earlier stages of clinical development for the intervention(s) being tested. The intervention(s) being tested in Phase III trials should also have adequate safety data for the populations under study.

Eligibility
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Funding
• Application budgets are not limited but need to reflect the actual needs of the proposed project. Applicants requesting USD $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/Research Contact at the NIH at least 6 weeks before submitting the application.
• The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Please see the Funding Opportunity Announcement for further information. Applications may be prepared and submitted via the NIH ASSIST system or Grants.gov. For complete instructions, you must refer to both the NIH Application Guide and the Funding Opportunity Announcement (FOA), noting that instructions in the FOA take precedence over the Application Guide.

Key Dates
Letter of Intent (non-mandatory) due to NIH: Not Applicable
Applications due to UQR&I: 22 January 2019
Applications close with NIH: 5 February 2019, 5:00pm local time of applicant organisation
Future application closing dates: Standard dates apply until expiry
Expiration date of FOA: 8 September 2021

Ahead of internal review, ensure all online components on ASSIST or Grants.gov are complete. To initiate review, email your completed Funding Application Coversheet to internationalgrants@research.uq.edu.au. Interested applicants are strongly encouraged to make contact with the UQR&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQR&I internal deadline to discuss their application.
Website: http://grants.nih.gov/grants/guide/pa-files/PAR-18-878.html

Return