The FDA has issued guidance to drug companies developing medication to treat Alzheimer’s before symptoms appear, sparking concerns about potential overdiagnosis. The guidance aims to address amyloid pathology that may occur decades before symptoms manifest, suggesting early intervention is crucial. Some experts, like Rudolph E. Tanzi, propose treating Alzheimer’s similar to heart disease, proactively addressing underlying issues to prevent future complications. However, others, like Dr. Eric Widera, caution against potential risks and question the efficacy of drugs targeting amyloid. The proposed changes could redefine Alzheimer’s, potentially leading to a surge in diagnoses among asymptomatic individuals. Tanzi emphasizes the need for early detection and intervention to effectively combat the disease. Dr. McCance expressed that while it is beneficial to pursue treatments for Alzheimer’s disease, the drug lecanemab is too expensive at over $60,000 per year. He is currently raising funds for a clinical trial initiative at the McCance Center for Brain Health to test affordable drugs and natural products as an alternative to lecanemab for lowering amyloid levels in the brain.
The FDA’s draft guidelines focus on using amyloid reduction as a surrogate endpoint to predict clinical benefit in Alzheimer’s trials. While the agency does not consider amyloid reduction as a primary endpoint, it suggests that it can serve as a surrogate endpoint to predict clinical benefit.
Researchers are exploring cognitive assessments and surrogate endpoints as alternatives to measure treatment effects in early Alzheimer’s stages, where cognitive and functional deficits may be limited. The FDA is considering these approaches to potentially shorten trial durations in early-stage disease.
The Alzheimer’s Association Workgroup proposed expanding the criteria for Alzheimer’s diagnosis based on biomarkers like amyloid instead of clinical syndromes. However, the American Geriatrics Society expressed concerns about overdiagnosis and the potential harm of initiating unproven treatments in asymptomatic individuals.
The AGS emphasized the importance of transparency in decision-making processes related to Alzheimer’s diagnosis and treatment and called for disclosure of any conflicts of interest. The FDA and Alzheimer’s Association Workgroup were contacted for comments but did not respond. Please rewrite this sentence.
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