Estimates of diagnosed dementia prevalence and incidence among diverse beneficiaries in traditional Medicare and Medicare Advantage.

Approximately half of Medicare beneficiaries are enrolled in Medicare Advantage (MA), a private plan alternative to traditional Medicare (TM). Yet little is known about diagnosed dementia rates among MA enrollees, limiting population estimates. All (100%) claims of Medicare beneficiaries using encounter data for MA and claims for TM for the years 2015 to 2018 were used to quantify diagnosed dementia prevalence and incidence rates in MA, compare rates to TM, and provide estimates for the entire Medicare population and for different racial/ethnic populations.

Impact of non-binding FDA guidances on primary endpoint selection in Alzheimer's disease trials.

Introduction: The U.S. Food and Drug Administration (FDA)'s guidances help describe the agency's current thinking on regulatory issues and serve as a means of informal policymaking that is non-binding.

Safety, tolerability, and pharmacokinetics of allopregnanolone as a regenerative therapeutic for Alzheimer's disease: A single and multiple ascending dose phase 1b/2a clinical trial.

Introduction: Allopregnanolone is an endogenous neurosteroid with the potential to be a novel regenerative therapeutic for Alzheimer's disease (AD). Foundations of mechanistic understanding and well-established preclinical safety efficacy make it a viable candidate.

Methods: A randomized, double-blinded, placebo-controlled, single and multiple ascending dose trial was conducted.