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Recruitment Underway for Amyloid PET Study to Assess Impact in Clinical Practice

ARTICLE IN BRIEF

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DR. JOHN C. MORRIS: “The study seeks to demonstrate that amyloid PET can help clinicians diagnose the cause of cognitive impairment, which will allow them to provide the most appropriate treatments and recommendations and improve health outcomes. We hope that the evidence obtained by the IDEAS study will support reimbursement of amyloid imaging by Medicare and other third-party payers.”

A new trial is recruiting patients to assess the impact of amyloid PET on short-term medical management and major medical outcomes over 12 months.

In 2016, the Imaging Dementia —Evidence for Amyloid Scanning (IDEAS) study begins recruitment. The first-of-its-kind study aims to determine whether or not amyloid PET imaging in a general clinical setting — not just in a clinical trial or at a tertiary care center — can affect the diagnosis and care of people with Alzheimer's disease (AD) whose cognitive symptoms cannot be definitively attributed to a cause by clinical diagnosis alone.

John C. Morris, MD, FAAN, the Friedman distinguished professor of neurology and director of the Knight Alzheimer Disease Research Center at the Washington University School of Medicine, spoke with Neurology Today about why the trial is important and how neurologists across the country can participate.

THERE HAVE BEEN RESEARCH STUDIES CONDUCTED ON AMYLOID PET IMAGING. WHY IS THIS STUDY LOOKING AT THIS IMAGING OUTSIDE OF A CLINICAL TRIAL SETTING?

Amyloid PET imaging has become standard for enrollment in clinical trials related to Alzheimer's and in major Alzheimer's disease centers like ours. There is wide support in the field for the standards for using amyloid imaging in clinical practice, articulated in the jointly released guidelines in 2013 by the Society for Nuclear Medicine and Molecular Imaging and the Alzheimer's Association.

Third-party payers, including the Centers for Medicare & Medicaid Services (CMS), continue to resist reimbursement for amyloid PET imaging. They suggest that there is a lack of strong evidence demonstrating that these scans do anything to improve patient outcomes. Some payers have said that in the absence of a disease-modifying AD therapy, getting an accurate diagnosis does not have a significant impact on a patient's health. This means that outside the setting of a clinical trial — where CMS covers a single amyloid PET scan if the trial meets certain criteria — patients with cognitive symptoms who are recommended for an amyloid PET scan must pay for it out of pocket. The exact cost varies based on a number of factors, but, for example, here at Washington University, the current out-of-pocket cost to the patient is about $4,300.

That's where IDEAS comes in. The study seeks to demonstrate that amyloid PET can help clinicians diagnose the cause of cognitive impairment, which will allow them to provide the most appropriate treatments and recommendations and improve health outcomes. We hope that the evidence obtained by the IDEAS study will support reimbursement of amyloid imaging by Medicare and other third-party payers.

IDEAS has two specific aims: to assess the impact of amyloid PET on short-term medical management, and on major medical outcomes over 12 months, such as hospital admissions and emergency department visits. Outcomes for patients enrolled in the study will be compared with matched patients who are not study participants.

PLEASE TELL US MORE ABOUT THE TRIAL DESIGN.

IDEAS is a four-year, observational, open-label, longitudinal cohort study being performed under CMS coverage with an [Coverage with evidence development is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data.] Dementia specialists at centers nationwide, including ours, will team up with radiologists and nuclear medicine physicians at PET facilities to order, conduct, and interpret the amyloid PET images. A total of 18,488 Medicare beneficiaries meeting eligibility criteria will be enrolled over the next 24 months.

WHAT TYPES OF PET IMAGING WILL BE STUDIED?

The study will include the three amyloid PET imaging radiopharmaceuticals that have been approved by the Food and Drug Administration for clinical use: florbetapir F 18 (Amyvid™), flutemetamol F 18 (Vizamyl™), and florbetaben F 18 (Neuraceq™).

WHAT ARE THE ENROLLMENT CRITERIA FOR PARTICIPATION IN THE TRIAL?

Patients interested in participating must undergo a comprehensive clinical evaluation by a dementia expert, including laboratory tests (complete blood count, comprehensive metabolic panel, thyroid function tests, and vitamin B12 level) and structural brain imaging (CT or MRI). To be eligible for the study, diagnostic uncertainty must remain after this comprehensive evaluation is completed. When there is some question regarding a patient's diagnosis, that is the scenario in which we believe amyloid PET imaging can be particularly helpful.

WHAT WILL PATIENTS AND THEIR FAMILIES HAVE TO DO DURING THE TRIAL?

Patients will have to participate in three clinical visits: the comprehensive diagnostic examination to determine eligibility and to formulate a management plan before PET, the PET scan visit, and a follow-up visit to document the management that has been instituted once the PET results are known.

After a community-practicing neurologist refers a patient to one of the IDEAS study sites, we will follow up with that physician to provide our findings and return the patient to the care of his or her regular neurologist.

WHO IS SPONSORING THE STUDY?

The Alzheimer's Association is the sponsor and the study will be managed by the American College of Radiology Imaging Network. Funding for the research comes from the Alzheimer's Association, the American College of Radiology, and the manufacturers of the FDA-approved radiopharmaceuticals for amyloid imaging. The actual cost of the PET scans will be paid by CMS as a covered service for Medicare beneficiaries.

WHO ARE THE LEAD INVESTIGATORS?

The study chair is Gil D. Rabinovici, MD, an associate professor of neurology at the University of California, San Francisco, who is a behavioral neurologist with research expertise in amyloid PET. The study co-chairs are Maria Carrillo, PhD, chief science officer with the Alzheimer's Association; Bruce E. Hillner, MD, professor emeritus at Virginia Commonwealth University; Barry A. Siegel, MD, a professor of radiology at Washington University; Constantine Gatsonis, PhD, from the department of biostatistics at Brown University School of Public Health; and Rachel Whitmer, PhD, a senior scientist and epidemiologist at Kaiser Permanente division of research.

HOW CAN I REFER PATIENTS?

The study will begin accrual in early 2016. At that time, neurologists can refer their patients to the nearest participating specialized center for screening. If they qualify as dementia experts, they also can sign up to be referring physicians for IDEAS. We anticipate that approximately 200 sites around the country will participate in the study. For more information about the IDEAS study and to find a study site nearby, visit www.ideas-study.org.

LINK UP FOR MORE INFORMATION:

•. Johnson KA, Minoshima S, Bohnen NI, et al. Update on appropriate use criteria for amyloid PET: A report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association http://www.ncbi.nlm.nih.gov/pubmed/23360977. Alzheimers Dement 2013; 9(1):e-1–16.
    •. Johnson KA, Minoshima S., Bohnen NI, et al. Update on appropriate use criteria for amloid PET imaging: Dementia experts, mild cognitive impairment, and education. Amyloid Imaging Task Force of the Alzheimer's Association and Society for Nuclear Medicine and Molecular Imaging http://www.alzheimersanddementia.com/article/S1552-5260(13)02462-X/abstract. Alzheimers Dement 2013;9(4):e106–109.