Clinical Effect of Amyloid PET Imaging Is Shown in the Initial Phase of a National Study
According to a groundbreaking nationwide research, clinical care of individuals with moderate cognitive impairment and dementia was profoundly impacted by a type of brain imaging that can identify “plaques” linked to Alzheimer’s disease.
In nearly two-thirds of cases, medical management, including the use of medications and counselling, was altered after clinicians were given the results of positron emission tomography (PET) scans that identify amyloid plaques in the brain. This is more frequently than anticipated before the study, according to researchers. More than one-third of research participants had their source of cognitive impairment incorrectly diagnosed before using the “amyloid PET imaging” approach.
The multicenter study of more than 11,000 Medicare beneficiaries was overseen by the American College of Radiology and led by researchers at the Alzheimer’s Association, UC San Francisco, Brown University School of Public Health, Virginia Commonwealth University School of Public Health, Washington University School of Medicine in St. Louis, UC Davis School of Medicine, and the Kaiser Permanente. It was published on April 2, 2019, in the Journal of the American Medical Association (JAMA).
Gil Rabinovici, MD, Distinguished Professor, the study’s lead author and principal investigator, said, “We are impressed by the magnitude of these results, which make it clear that amyloid PET imaging can have a major impact on how we diagnose and care for patients with Alzheimer’s disease and other forms of cognitive decline.”
member of the UCSF Weill Institute for Neurosciences and professor of neurology at the Memory and Aging Center.
Maria C. Carrillo, PhD, chief science officer of the Alzheimer’s Association and a co-author of the study, said, “These results present highly credible, large-scale evidence that amyloid PET imaging can be a powerful tool to improve the accuracy of Alzheimer’s diagnosis and lead to better medical management, especially in difficult-to-diagnose cases. “It is crucial that individuals who require it have more access to amyloid PET imaging.”
Both amyloid protein plaques and tau protein “tangles,” which must both be present for a conclusive diagnosis, accumulate in the brain in Alzheimer’s disease. Up until recently, the only way to identify amyloid plaques was through postmortem examination of autopsied brain tissue. With the introduction of amyloid PET, which involves giving patients “tracer” molecules that adhere to amyloid plaques and can be used to see where they are in the brain, it is now feasible to see plaques during a brain scan and therefore more precisely diagnose those who have the condition.
Despite the fact that there is no cure for Alzheimer’s disease, early detection allows doctors to recommend the most suitable symptom-management treatments, advise families on crucial safety and care-planning problems, and point them in the direction of scientific trials for exciting new medications. Moreover, it enables those who have the condition and their families to make future plans, take care of financial and legal matters, and have access to resources and support systems. Memory loss can have alternative and occasionally reversible reasons, such as pharmaceutical side effects, sleep or mood difficulties, and other medical illnesses, which might trigger an examination for PET imaging findings that show no evidence of amyloid deposition in the brain.
Unfortunately, despite the FDA’s approval of amyloid PET tracers, Medicare or health insurance companies presently do not cover the use of amyloid PET imaging to help with the precise diagnosis of the cause of someone’s dementia, rendering it unavailable to the majority of individuals.
The Imaging Dementia – Evidence for Amyloid Scanning (IDEAS) study, which began in 2016, was designed by a group of scientists brought together by the Alzheimer’s Association to examine whether teaching medical staff about the findings of amyloid PET imaging would alter how they treat patients with memory loss and cognitive decline. More than 16,000 Medicare seniors with moderate cognitive impairment or dementia of unknown aetiology were participated in the IDEAS study, which attracted close to 1,000 dementia specialists to 595 locations around the United States. Its Coverage with Evidence Development policy states that As a part of this clinical trial, the Centers for Medicare & Medicaid Services (CMS) paid for amyloid PET scans completed at 343 sites and analysed by more than 700 imaging professionals.
This study examined the effects of amyloid PET imaging in community clinics and other non-academic settings, showing for the first time how big of an influence this technology has on dementia treatment in the real world, according to Rabinovici.
The 11,409 people who successfully finished the trial were the subject of the newly released findings from the IDEAS project’s first phase, which examined how amyloid PET scans changed doctors’ diagnoses and treatment regimens. The investigators gathered information on how doctors changed participants’ pharmaceutical prescriptions and counselling on safety and future planning as the study’s main goal. The researchers also looked at whether changes in participant diagnoses were a result of PET imaging data. Physician choices about referrals to Alzheimer’s clinical trials were also included in a number of experimental objectives.
According to recently released data, more than 60% of the study’s subjects had their clinical care modified by their doctors, which is more than double what the authors had anticipated.
Clinicians were twice as likely to prescribe Alzheimer’s medicines after PET imaging (40% prior to imaging vs. 82%) among patients who entered the research with moderate cognitive impairment and whose brain scans confirmed the presence of substantial amyloid deposits. Following the trial, prescriptions for these medications increased from 63% to 91% among people with dementia and high amyloid deposition on PET scans. Several individuals who had scans that showed little amyloid buildup had their usage of these medications stopped by their doctors. Also, for about 25 percent of research participants,
Based on the results of the PET imaging, doctors modified counselling and non-medicine Alzheimer’s prescriptions.
For almost one third of individuals who had been previously diagnosed with Alzheimer’s disease, doctors excluded the condition after PET scans showed no substantial amyloid accumulation. On the other hand, nearly half of patients who had not previously been diagnosed with the condition received a new diagnosis of Alzheimer’s disease as a result of PET scans that revealed a large accumulation of amyloid plaque.
Also, the researchers found that one-third of participants who had previously been sent to Alzheimer’s clinical trials had no evidence of amyloid deposition based on PET imaging, therefore ruling out Alzheimer’s disease as the source of their cognitive problems. Physicians were able to guarantee that virtually all patients sent to Alzheimer’s trials were amyloid-positive based on the imaging results (93 percent),This is essential for the success of these experiments.
“To ensure that patients receive the best therapies, accurate diagnoses are essential. According to Rabinovici, drugs for Alzheimer’s disease in particular can make cognitive decline worse in patients with other brain disorders. But perhaps more importantly, those who visit the clinic with questions about memory issues seek solutions. People may be able to participate in preparing for the next stage of their life and make decisions that would otherwise need to be made by others if they receive an early, conclusive diagnosis.
The second part of the IDEAS project, which will look at how amyloid PET scans impact health outcomes after the scan, is presently undergoing data analysis. Hospitalization rates and Emergency Department visits for IDEAS members are being recorded and compared by the researchers using CMS claims data.
participants who had amyloid PET but did not have patients with comparable neurologic issues. In 2020, they want to publish their research. A second project, called New IDEAS, is also being developed by the researchers to enrol more individuals with both typical and atypical clinical manifestations of Alzheimer’s disease and to better represent the racial and socioeconomic variety of the general community.
Leadership of the IDEAS Study: Constantine Gatsonis, PhD, of the Brown University School of Public Health, Bruce Hillner, MD, of Virginia Commonwealth University, Barry Siegel, MD, of the Washington University School of Medicine in St. Louis, and Rachel Whitmer, PhD, of the UC Davis School of Medicine and the Kaiser Permanente Division of Research, in Oakland, California, are the other co-chairs of the IDEAS Study. Rabinovici and Carrillo are also co-chairs. For a complete list of authors and affiliations, visit the study’s website.
The Alzheimer’s Association, the American College of Radiology, Avid Radiopharmaceuticals, Inc. (an entirely owned subsidiary of Eli Lilly and Company), General Electric Healthcare, Life Molecular Imaging, and the American College of Radiology all provided funding for the trial (formerly Piramal Imaging). The Centers for Medicare and Medicaid Services paid for the PET scans used in this investigation.
The 2013 National Coverage Determination on Amyloid PET Imaging in Dementia and Neurodegenerative Disease (CAG-00431N) by CMS to not cover these scans for Medicare subscribers prompted the development of the IDEAS Project. CMS’s “coverage with evidence development” programme paid for participants in the IDEAS study’s amyloid PET scans. The goal of the initiative for developing coverage with evidence is to collect more data in order to guide future coverage decisions.
Information disclosed: Rabinovici has held positions on the advisory boards for Merck, Eisai, Genentech, and Roche. He is an associate editor for JAMA Neurology and receives funding for his research from Eli Lilly & Company and Avid Radiopharmaceuticals. Blue Earth Diagnostics and GE Healthcare both have Siegel on their advisory boards. He has been compensated for his advice by BTG and Avid Radiopharmaceuticals.
Leading university UC San Francisco (UCSF) is committed to improving patient care, graduate-level education in the life sciences, and global health via its advanced biomedical research. It consists of a graduate division with nationally acclaimed programmes in fundamental, biomedical, translational, and population sciences, a top-tier biomedical research enterprise, and top-ranked graduate schools of dentistry, medicine, nursing, and pharmacy. It also includes UCSF Health, which consists of three highly regarded hospitals, including the Langley Porter Psychiatric Hospital and Clinics, UCSF Benioff Children’s Physicians, and the UCSF Faculty Practice. These hospitals are the UCSF Medical Center and UCSF Benioff Children’s Hospitals in San Francisco and Oakland. The Bay Area’s hospitals and healthcare institutions are connected to UCSF Health. All medical treatment is also provided by UCSF professors at the all across the Bay Area. In the public Zuckerberg San Francisco General Hospital and Trauma Center as well as the SF VA Medical Center, all medical care is provided by UCSF staff. A significant division of the University of California, San Francisco School of Medicine is the UCSF Fresno Medical Education Program.
In relation to the Alzheimer’s Association: The major nonprofit health group for Alzheimer’s care, support, and research is the Alzheimer’s Association. Our goal is to lower the risk of dementia by promoting brain health, to offer and improve treatment and support for everyone affected by Alzheimer’s disease, and to completely eradicate the illness. Our goal is to eradicate Alzheimer’s disease. Call 800.272.3900 or go to https://thenewsidea.com
