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)

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This RFA is soliciting applications proposing placebo-controlled, 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 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 Alzheimers 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) a clinical LBD diagnosis, i.e. Parkinsons disease dementia (PDD) and/or dementia with Lewy bodies (DLB). 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.