Alzheimer’s Association

The Alzheimer’s Association brought together and led the initial IDEAS Study workgroup, convening various stakeholders and thought leaders in order to develop a national Coverage with Evidence Development protocol in response to the CMS National Coverage Decision. The Association identified and convened the IDEAS Study leadership team, and worked with that team and CMS to develop the study protocol.

Maria Carrillo, PhD, Alzheimer’s Association chief science officer, is a co-chair of the study, and will participate in guiding the data analyses, interpretation of the data analyses, ongoing oversight, and decision making as well as communications for recruitment of participants, referring physicians, and study sites.

The Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) were also instrumental in convening the workgroup that developed Appropriate Use Criteria (AUC) for brain amyloid PET scans.

American College of Radiology

The American College of Radiology (ACR®) is a professional medical society dedicated to serving patients and society by empowering radiology professionals to advance the practice, science, and professions of radiological care. The ACR provides leadership and logistical support for the IDEAS Study.

The American College of Radiology Imaging Network (ACRIN®) is the clinical research center of the ACR and has worked on the development of IDEAS and writing of the protocol through the efforts of Barry Siegel, MD, FACR, Bruce Hillner, MD, and Constantine Gatsonis, PhD. ACRIN will provide scientific leadership to the study to include study design, analysis, and dissemination and will provide ongoing oversight and decision making.

CENTER FOR STATISTICAL SCIENCES, BROWN UNIVERSITY SCHOOL OF PUBLIC HEALTH

The Biostatistics Center of the IDEAS Study is located at the Center for Statistical Sciences (CSS) of the Brown University School of Public Health. CSS has deep expertise and experience in the evaluation of diagnostic and screening modalities. Under the direction of Prof. Constantine Gatsonis, Biostatistics Center faculty and staff provide methodologic expertise, leadership and support in all phases of the IDEAS Study, including design, study monitoring, analysis of clinical and medical claims data, and preparation of reports and manuscripts.

Centers for Medicare & Medicaid Services (CMS)

CMS provided advice and guidance over the course of the planning and writing of the IDEAS Study protocol. In the study, CMS will provide coverage for the PET scans per its Coverage with Evidence Development policy.

Manufacturers of FDA-approved amyloid radiopharmaceuticals

Through the Medical Imaging & Technology Alliance (MITA), manufacturers of amyloid radiopharmaceuticals, have provided advice over the course of the planning and writing of the study protocol. They will be a part of the implementation stage of the study protocol as it is launched; exact roles are being discussed now, and may include funding and communications for recruitment of participants, referring physicians, and facilities that offer PET scans. Manufacturers will also be represented on the IDEAS Study Steering Committee.