Early-Stage Therapy Development for ADRD (R61/R33 Clinical Trial Not Allowed)

Funding Agency:
National Institutes of Health

This funding opportunity announcement (FOA) encourages early-stage development of novel small molecule or biologic therapeutics for NINDS mission-relevant Alzheimer's and related dementias: frontotemporal degeneration (FTD, including Pick’s disease and progressive supranuclear palsy), Lewy body dementias (LBD; including dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), and multiple etiology dementias (MED). This FOA covers four stages of early therapy discovery/development with each stage gated by go/no-go milestones. Applicants may enter the program at the stage appropriate to their research. The R61 phase supports preparatory research stages 1 -3: 1) development of in vitro and/or ex vivo assays that can support therapeutic screening efforts, 2) screening efforts to identify and characterize potential therapeutic agents, and 3) therapeutic optimization, pharmacodynamic and pharmacokinetic studies. The R33 phase supports stage 4, in vivo efficacy studies in an animal model of disease. This FOA supports research to enable competitive follow-on applications that meet the entry criteria for the Blueprint Neurotherapeutics Network, Blueprint Biologics, or other similar later-stage translational programs.


  • Letter of Intent: Sep. 30, 2022
  • Application: Oct. 31, 2022

RFA-NS-22-059 Expiration Date November 01, 2022

Agency Website

Amount Description

Direct costs cannot exceed $500,000 in any one year.

The total project period for a combined R61/R33 application submitted in response to this FOA may not exceed five years, with no more than four years for the R61 phase and no more than three years for the R33 phase. Applications proposing less than 4 stages of work are expected to request less time.

Funding Type





Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

October 31, 2022