Request for Proposal: Biomarkers Development
Clinical trials for Alzheimer's disease and related dementias have been hindered, in part, by the limited number of biomarkers available to (1) accurately diagnose these diseases, (2) enrich and stratify patient cohorts, (3) demonstrate target engagement for novel therapeutics, and (4) reliably monitor disease progression and response to treatment. While currently available biomarkers have helped to accelerate clinical trials, most are either expensive, invasive, or both, and provide information on a small number of disease targets. Thus, additional biomarkers are needed to provide a more complete picture of the disease.
This Request for Proposals (RFP) seeks to support the development and validation of biomarkers that will enhance the design and performance of clinical trials for Alzheimer's disease, related dementias, and cognitive aging.
Average Duration: 1-2 years
Average Award: $150,000-$300,000/year
UPCOMING DEADLINES (4/year)
Must be received by 11:59 pm EST on the deadline date.
Letter of Intent: February 17, 2017
Invited Full Proposal: March 10, 2017
Letter of Intent: May 19, 2017
Invited Full Proposal: June 9, 2017
Letter of Intent: July 31, 2017
Invited Full Proposal: September 8, 2017
Letter of Intent: November 17, 2017
Invited Full Proposal: December 8, 2017
Proposal submissions should focus on further development of biomarkers previously identified in samples from well-characterized human subjects, supported by a reasonable body of preliminary data Biomarkers should have a rational biological connection to the disease process. Validated methods should be used in quantifying and qualifying biomarkers, and there is lower enthusiasm for developing novel technologies.
Priority Biomarker Areas
- Companion Biomarkers – Biomarkers that can assess target engagement and disease modification of specific clinical-stage therapeutics
- Neuroimaging – Positron emission tomography (PET) ligands for target engagement and pharmacodynamic measurements of novel and repurposed therapeutics, and novel magnetic resonance imaging (MRI) methods to measure structural, blood flow, and white matter changes in the brain
- CSF and blood-based biomarkers – Multiplex ELISA and mass spectrometry of particular target(s) or transcriptomics, proteomics, metabolomics, and lipidomics signatures
- Functional activity measures – Electroencephalogram (EEG), magnetoencephalography (MEG), transcranial magnetic stimulation (TMS)
- Other novel approaches that are supported by compelling evidence
With regards to potential drug targets:
The ADDF is particularly interested in developing and validating biomarkers for, but not limited to, neuroinflammation, neuronal degeneration, synaptic activity, mitochondria/metabolic function, proteostasis, blood-brain barrier integrity/vascular injury, calcium regulation, oxidative stress, and white matter changes.
The ADDF has limited interest in funding measures of cognition and function, as well as CSF assays of Aβ and tau levels.
- Academic Investigators seeking to create and support innovative biomarker programs in academic medical centers and universities.
- Biotechnology companies with programs dedicated to Alzheimer's disease biomarker development – New biotechnology company spinouts or existing biotechnology companies that demonstrate a clear need for non-profit funding are eligible to apply. Funding is provided through mission-related investments (MRIs) that require return on investment based upon scientific and/or business milestones.
Application Submission Guidelines
The ADDF provides typically supports 1-2 years of research at a time, with potential for future follow-on funding. Funding can range from $150,000-$300,000 per year depending on the stage of research, and must be justified based on the scientific work plan. In some cases, multi-year projects can be considered. Inquiries with the ADDF staff are encouraged to determine the Foundation's interest prior to application.
All applicants are required to complete an electronic "Letter of Intent" (LOI). After review of the LOI, ADDF may invite a full application via email with a link to the electronic application form. The ADDF will attempt to make a determination of interest within 90 days of receipt of the application.
For program-related inquiries, please contact:
Andrew Koemeter-Cox, PhD, Scientific Program Officer
For application submission inquiries, please contact:
Grants and Contracts Team