Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial Optional)

Background
The National Institute on Aging (NIA), as the primary federal agency for AD research, supports research spanning from basic understanding of disease pathology to clinical intervention, to public health outcomes.

Despite the discovery of many candidate biomarkers for AD/ADRD, few of them progress to validation, and their clinical and scientific utility remain indeterminate. A particularly pressing issue is the co-occurrence of AD and ADRD pathologies, since autopsies show that neuropathological comorbidities are common in the brains of people who lived with dementia.

Grant Details
This Notice of Funding Opportunity (NOFO) aims to accelerate the establishment of effective and reliable biomarkers of Alzheimer’s disease (AD) and AD-related dementias (ADRD) for use in therapy/medical product discovery and development, clinical trials, and/or clinical practice.

Specifically, this NOFO will support analytical and/or clinical validation of a biomarker, composite biomarker, or biomarker signature, with rigor comparable to the expectations described in the FDA's Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways. The research strategy must clearly describe how the investigators will utilize rigorous design, execution, and analysis of the data for the purpose of validation.

For Analytical Validation, criteria for validation should be clearly described; specific metrics should be identified as appropriate for the biomarker category, modality and COU. In general, Analytical Validation may include assessment of accuracy, precision, analytical sensitivity, analytical specificity, reportable range of test results for the test system, reference intervals with controls and calibrators.

Clinical validation should definitively test the ability of the biomarker to identify, measure, or predict a meaningful clinical state. Specific metrics for clinical validation should be identified as appropriate for the biomarker category, modality and COU.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status (other than institutions of higher education), small businesses, state governments, county governments, city or township governments,
special district governments,
Indian/Native American tribal governments (federally recognized), independent school districts,
public housing authorities/Indian housing authorities,
Native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations.

Period of Performance
The project period is limited to 5 years for projects proposing research on both analytical and clinical validations or clinical validation only. For projects proposing research on analytical validation only,
the project period is limited to 4 years.

Grant Value
Application budgets are not limited but need to reflect the actual needs of the proposed project. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.