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

Funding Agency:
National Institutes of Health

This RFA is soliciting applications proposing placebo-controlled, phase 3 clinical trials to determine the efficacy and safety of FDA approved monoclonal antibody therapies directed against amyloid compared to placebo in diverse "mixed dementia" populations with a focus on vascular contributions to cognitive impairment and dementia (VCID). 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 deposition assessed using positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) with evidence of vascular contributions based on imaging (for example, white matter disease and/or subclinical infarction). Bayesian approaches with response adaptive randomization to examine specific subgroups are encouraged. Successful applications will be powered to determine efficacy in diverse populations representative of the distribution of the disease in the United States by sex, race/ethnicity, and geographic distribution. Applications must include elements of patient and community engagement that are incorporated into all stages of program development and at all levels of the organizational structure.

Deadlines:

  • Letter of Intent Due Date(s): April 20 , 2024 

  • Application Due Date: May 20, 2024

RFA-NS-24-013 Expiration Date New Date May 21, 2024 (Original Date: February 21, 2024) per issuance of NOT-NS-24-044

Agency Website

Amount

$46,900,000

Amount Description

Direct Costs cannot exceed $6,700,000 per year and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period.  The maximum project period is 7 years.  

Funding Type

Grant

Eligibility

Faculty

Category

Community Outreach and Engagement
Medical
Medical - Clinical Science

External Deadline

May 20, 2024