Related Announcements

PAR- 21-360 - Pilot Studies for the Spectrum of Alzheimer’s Disease/Alzheimer’s Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)

Issued by

National Institute on Aging (NIA)

Purpose

This Notice clarifies the Research Objectives of Funding Opportunity Announcement (FOA) PAR 21-360, Pilot Studies for the Spectrum of Alzheimer’s Disease/Alzheimer’s Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)." The Research Objectives are found in Section 1 of the FOA, and state the following:

"This FOA invites research grant applications that enable the collection of pilot data to support early-stage testing of promising pharmacological and non-pharmacological interventions that target deleterious cognitive and neuropsychiatric changes associated with age-related cognitive decline and AD/ADRD across the spectrum from pre-symptomatic to more severe stages of disease. Pilot data should be focused on addressing issues of feasibility, safety, and tolerability/acceptability. Furthermore, these data should inform aspects of subject selection, design, and endpoints of subsequent trials. The goal of these pilot data is to serve as preliminary data for applications to the early stage and late stage clinical trial PAR-21-359."

Clarification

A pilot study is defined as a small-scale test of the methods and procedures to be used on a larger scale. The goal of PAR 21-360 is to enable the collection of pilot data that will serve as preliminary data for applications to the early stage and late stage clinical trial PAR-21-359. As such, applications to PAR 21-360 must include clinical investigations as a central objective to the proposed study. Applications can also include preclinical objectives to support translation to clinic.

Inquiries

Please direct all inquiries to:

Akanni Clarke, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: akanni.clarke@nih.gov