US National Institutes of Health – Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) – PAR-18-877
Sponsor: US National Institutes of Health
Closing Date: 05-Feb-2019
The purpose of this Funding Opportunity Announcement (FOA) is 1) to invite applications that propose to develop and implement early stage (Phase I or II) clinical trials of promising pharmacological and non-pharmacological interventions in individuals with age-related cognitive decline and in individuals with Alzheimer's disease (AD) across the spectrum from pre-symptomatic to more severe stages of disease, and 2) to stimulate studies to enhance trial design and methods.

Examples of interventions for evaluation include but are not limited to:
• pharmacological interventions that target eradication or progression of deposition of disease neuropathology;
• repurposed drugs that have promise for AD treatment such as chemotherapeutic agents or drugs for insulin dysregulation/diabetes;
• novel cognitive training or cognitive engagement approaches;
• aerobic exercise and/or other movement therapies, such as Tai Chi;
• sleep enhancement;
• mindfulness-based stress reduction;
• nutritional supplementation or adoption of specific dietary programs; and/or
• combinations of interventions including the mixture of pharmacological with non-pharmacological therapeutics.

This FOA encourages clinical trial applications including but not limited to the following:
• Studies to refine the intervention strategy. These studies could include work to determine appropriate dosage of drugs, duration of treatment, and the delivery system. For non-pharmacological interventions, such work might examine the intensity or duration of therapy required. For all interventions, the potential synergistic effects of combined interventions could be explored.
• Studies to evaluate the safety and/or efficacy of the intervention(s).
• Studies that elucidate mechanism of action. In some cases, there may be interventions that have some level of demonstrated efficacy (e.g., exercise for age-related cognitive decline), but lack a real understanding of the mechanism of action. Work in this area could use a variety of approaches appropriate to the intervention to elucidate the mechanism of action and therefore allow both confirmation of engagement of the intervention target and potentially optimize the intervention.
• Studies to define and refine the target population and ensure adequate enrollment, protocol adherence and subject retention.
• Studies that address heterogeneity of response. This would include identification of specific individuals according to genetic profiles, behavioral factors, and/or sociocultural or demographic factors who are more likely or less likely to benefit from the intervention(s). Mediators of the therapeutic intervention such as continued educational opportunities and continued engagement in driving or financial decision-making may facilitate real-life function and should be considered.
• Studies to establish/validate trial outcome measures. These measures may include clinical/neuropsychological/behavioral measures, neuroimaging measures, and other biological measures in blood and cerebrospinal fluid.

The National Institute of Nursing Research (part of NIH) is particularly interested in pilot clinical trials addressing behavioral (non-pharmacological) interventions.

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-18-877.html

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