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)
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).
- Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Visit funding web page
(https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-010.html)
