Does the FDA Have Dementia?

This is a portion of a copyrighted article from New England Journal of Medicine shared here for informative purposes on a topic of great public interest and therefor falls under the "fair use" exception to the US Copyright Laws.

It's on the topic of treating Alzheimer's Disease and even here you can see how even the best neuroscientists can get careless their word usage.

"An estimated 50 million people worldwide have dementia, mostly due to Alzheimer’s disease... costing approximately $1 trillion annually... likely to increase [as population ages].... the results of TRAILBLAZER-ALZ, a phase 2 clinical trial of... an antiamyloid monoclonal antibody... 257 participants with early Alzheimer’s disease were randomly assigned to receive... or placebo... The prespecified primary outcome goal was met... 25 to 30% less decline than placebo... these findings, which amounted to a 3-point difference on a scale ranging from 0 to 144, barely showed significance (P=0.04), and the clinically relevant secondary outcomes of dementia severity, cognition, and functional abilities all failed to show treatment effects. Nevertheless, the results warrant further study of...

Disease-modifying treatments for Alzheimer’s disease have mostly targeted the amyloid plaques that are a hallmark of the disease, but repeated trial failures have led many to question this choice of target.... until recently, trials testing these drugs have been unsuccessful...

Treatments for Alzheimer’s disease will require a transformation of health care practice. Early and specific diagnosis is essential... treatment benefit is expected only when treatment is started at the very early stages of disease... in the absence of effective treatments, evidence to support screening for dementia has been considered “insufficient” by the U.S. Preventive Services Task Force... The Medicare Annual Wellness Visit was introduced to help address this deficiency; however, even with reimbursement for the assessment, its adoption in practice has been low, and some studies suggest that such visits have little effect on the diagnosis of dementia.

If antiamyloid treatments are shown to be successful, precise staging of Alzheimer’s disease may be required. In this trial, PET scans were used to quantify both plaques and tangles in order to stringently select participants with Alzheimer’s disease in the earliest stages. These narrow indications will restrict eligibility for treatment, and requirements for confirmation by biomarker testing may pose additional barriers. In the trial, only 1 in 10 screened participants met the enrollment criteria. The adverse events of amyloid-related imaging abnormalities occurred in more than one third of participants who were treated... The high prevalence of Alzheimer’s disease, the shortage of specialists in the field of dementia disorders, and the expense and availability of biomarker testing for diagnosis and staging all pose challenges in the implementation of disease-modifying treatments for Alzheimer’s disease...

Black and Hispanic or Latino people are disproportionately affected by Alzheimer’s disease, yet they are less likely to receive timely diagnosis and treatment than people of other racial or ethnic backgrounds... Black patients with Alzheimer’s disease may have lower tau levels than non-Hispanic White patients, which poses a risk of false negative diagnosis and underestimated staging for Alzheimer’s disease among Black patients. The safety and efficacy of new treatments in minority populations is impossible to know, given how few have participated in clinical trials; only approximately 3% of participants in this trial were Black and 1% Asian..."