CNN is set to air “Dr. Sanjay Gupta Reports: The Last Alzheimer’s Patient” on Sunday, July 7, at 8 p.m. ET. As the FDA prepares to make a decision on another expensive Alzheimer’s disease treatment, the nonprofit Alzheimer’s Association has finalized its new diagnostic criteria for the disease. In a significant change, doctors diagnosing Alzheimer’s are now being urged to rely on biomarkers such as beta amyloid and tau proteins detected through lab tests or brain scans, rather than traditional pen-and-paper memory tests.
The new criteria aim to detect the disease in its earliest stages, even before symptoms appear. This represents a shift towards diagnosing based on biology rather than symptoms. Critics argue that this could lead to an increase in misdiagnoses and unnecessary treatments, as beta amyloid proteins can be present in individuals without causing any dementia symptoms.
Recent clinical trials have shown some promise in treating Alzheimer’s with new drugs that target beta amyloid in the brain. The FDA recently approved the antibody lecanemab, which slowed cognitive decline in early-stage Alzheimer’s patients by 27%. Another experimental drug, donanemab, reduced disease progression by about 35%. These medications, however, come with potential risks such as brain fluid accumulation and microbleeds.
The Alzheimer’s Association’s new criteria have faced criticism from external experts and watchdog groups who believe the guidelines could be financially motivated to benefit drug manufacturers. Dr. Adriane Fugh-Berman from Georgetown University’s PharmedOut program, for example, argues that mislabeling individuals as having Alzheimer’s could have detrimental effects on thousands of people’s lives.
Despite the controversy, the Alzheimer’s Association defends its criteria as reflecting the latest scientific advancements in Alzheimer’s research. The organization emphasizes the importance of advancing diagnosis, treatment, and prevention to improve individual care and mitigate the societal impact of Alzheimer’s.
The development of the criteria involved a 20-member working group with varying ties to pharmaceutical companies, prompting concerns about conflicts of interest. The guidelines have been described as a marketing strategy to expand the market for new Alzheimer’s drugs by broadening the population diagnosed with the disease.
Dr. Clifford Jack from the Mayo Clinic, who led the development of the criteria, maintains that the committee strived to incorporate diverse viewpoints and scientific knowledge. The guidelines acknowledge the availability of new drugs and blood tests for Alzheimer’s proteins, signaling a shift towards more precise and early diagnosis of the disease.
The FDA has yet to approve the biomarker tests used in the new criteria, as they require further validation to ensure accuracy and reliability. Despite criticisms and skepticism surrounding the revised guidelines, the Alzheimer’s Association stands by its commitment to advancing Alzheimer’s research and care through evidence-based criteria development.
