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 original study protocol.
The Alzheimer’s Association’s participation and leadership will continue in a similar capacity for the duration of the New IDEAS Study. Maria Carrillo, PhD, Alzheimer’s Association chief science officer, is a co-chair of the study, and will participate in guiding and interpreting the data analyses, 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 were also instrumental in convening the workgroup that developed Appropriate Use Criteria (AUC) for brain amyloid PET scans.
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 the IDEAS and New IDEAS studies. ACRIN will provide scientific leadership, including study design, analysis and dissemination, while providing ongoing oversight and decision making as the designated operational center for the study.
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.
CMS provided advice and guidance over the course of the planning and writing of the New IDEAS Study protocol. During the study, CMS will provide coverage for Amyloid PET scans per its Coverage with Evidence Development policy. See additional information regarding CMS coverage requirements and processes.
The New IDEAS study is funded by contributions from the following manufacturers of FDA-approved amyloid radiopharmaceuticals:
Each manufacturer will participate in the implementation stage of the study protocol by facilitating communication for the recruitment of study participants, referring physicians, and facilities that offer PET scans. All three companies will have representation on the New IDEAS Study Steering Committee and provide advice and decision making throughout the duration of the study.
The study team gratefully acknowledges the contributions of our collaborators from the Society for Nuclear Medicine and Molecular Imaging, the Medical Imaging and Technology Alliance, and Alzheimer’s Therapeutic Research Institute at the University of Southern California Keck School of Medicine.