Funding Opportunities

PDBP Funding opportunities (FOAs) support discovery projects designed to promote the identification of promising diagnostic and progression biomarkers for Parkinson's disease.

Mechanisms of Cognitive Fluctuations in ADRD Populations (R01 - Clinical Trial Optional)

Annoucement Type:
New
Application Due Date:
Activity Code:
R01 Research Project Grant
FOA Number:
RFA-NS-25-014
Contact:
Debra Babcock, PhD, MD

Funding Opportunity Purpose

This Notice Of Funding Opportunity invites research applications focused on understanding the underlying pathophysiology of cognitive fluctuations in people diagnosed with Alzheimer’s Disease- Related Dementias (ADRD).  Researchers should propose a clear hypothesis for one or more etiologies that can be measured with standardized assessments (e.g., clinical evaluations, blood tests, electrophysiology, etc.) that can be collected across multiple time points and/or diagnoses.  The use of digital measures capable of capturing fluctuations in real time are highly encouraged.   

Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)

Annoucement Type:
Reissue of PAR-19-070
Application Due Date:
Activity Code:
R01 Research Project Grant
FOA Number:
PAR-22-093
Contact:
Rod Corriveau, PhD (roderick.corriveau@nih.gov)

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing research on current topics in Alzheimer's disease (AD) and its related dementias (ADRD). Further information on the high-priority topics of interest will be announced through a series of Notices published subsequent to this FOA. 

*Multiple due dates - see FOA

NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required)

Annoucement Type:
Reissue of PAR-18-422
Application Due Date:
Activity Code:
UG3/UH3
FOA Number:
PAR-21-237
Contact:
Jeremy Brown, MD

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS) to establish the efficacy (or compare the effectiveness) of treatment interventions.  These Phase 3, Phase 4 or Pivotal trials must address questions within the mission and research interests of the NINDS and may include studies of drugs, biologics, and devices, as well as surgical, behavioral or rehabilitation therapies.

*Multiple due dates - see FOA

Safety and Efficacy of Amyloid-Beta Directed Antibody Therapy in Mild Cognitive Impairment and Dementia with Evidence of Lewy Body Dementia and Amyloid-Beta Pathology (U01 - Clinical Trial Required)

Annoucement Type:
New
Application Due Date:
Activity Code:
U01 Research Project – Cooperative Agreements
FOA Number:
RFA-NS-25-010
Contact:
Rebecca Hommer, MD

Funding Opportunity Purpose

This RFA is soliciting applications proposing Phase 2 placebo-controlled, clinical trials to determine the safety and efficacy of monoclonal antibody therapies directed against amyloid-beta compared to placebo in diverse "mixed dementia" populations with a focus on Lewy Body Dementias (LBD). In this NOFO the mixed-etiology dementias (MED) that are of interest and that are in scope are cognitive impairment and dementia cases positive for 1) canonical Alzheimer’s pathology biomarkers (for example, amyloid-beta deposition assessed using positron emission tomography and/or low cerebrospinal fluid amyloid-beta 42 combined with elevated phosphorylated tau; and 2) a clinical LBD diagnosis, i.e. Parkinson’s disease dementia (PDD) and/or dementia with Lewy bodies (DLB).

Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)

Annoucement Type:
Reissue of PAR-19-315
Application Due Date:
Activity Code:
R61/R33 Exploratory/Developmental Phased Award
FOA Number:
PAR-22-089
Contact:
Carol Taylor-Burds, PhD (carol.taylor-burds@nih.gov)

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to promote the development of fit-for-purpose candidate biomarkers and biomarker signatures that enable more efficient clinical trials to advance therapeutic development or be used in clinical practice to help guide clinical care decisions. Specifically, the goal of this phased funding mechanism is to first identify or confirm candidate biomarkers or biomarker signatures using human samples and/or data, followed by an independent retrospective or prospective clinical study to conduct initial clinical validation of the biomarker/signature’s clinical utility for a defined Context of Use(s). In the first phase, applicants are expected to demonstrate that the biomarker acceptably identifies or predicts the concept of interest and may include optimization of the detection method using carefully standardized human samples or datasets. The overarching purpose of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.

*Multiple due dates - see FOA

Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

Annoucement Type:
Reissue of PAR-21-056
Application Due Date:
Activity Code:
U01 Research Project – Cooperative Agreements
FOA Number:
PAR-24-095
Contact:
Mary Ann Pelleymounter & Carol Taylor-Burds

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice.  Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

Annoucement Type:
Reissue of PAR-21-057
Application Due Date:
Activity Code:
U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Fast Track
FOA Number:
PAR-24-098
Contact:
Carol Taylor-Burds, PhD (carol.taylor-burds@nih.gov)

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice.  Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required. 

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

Annoucement Type:
Reissue of PAR-21-058
Application Due Date:
Activity Code:
U01 Research Project – Cooperative Agreements
FOA Number:
PAR-24-097
Contact:
Carol Taylor-Burds, PhD (carol.taylor-burds@nih.gov)

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO)is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

Annoucement Type:
Reissue of PAR-21-059
Application Due Date:
Activity Code:
U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Fast Track
FOA Number:
PAR-24-096
Contact:
Carol Taylor-Burds, PhD (carol.taylor-burds@nih.gov)

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.