The New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study is a novel Coverage with Evidence Development Study that will build upon the results from the original IDEAS Study. New IDEAS will address additional gaps in knowledge that are highly relevant to improve precision in future coverage decisions and implementation of amyloid PET in clinical practice. A major limitation of the original IDEAS cohort is lack of racial and ethnic diversity, with 88% of participants identified as non-Hispanic White/Caucasian. In addition, patients with typical clinical presentations of Alzheimer's disease were not included in the original IDEAS Study, and ApoE genotyping was not performed. These limitations of the original IDEAS Study will be addressed by the New IDEAS Study, while also directly responding to the amyloid PET imaging CED provision #2: “Are there specific subpopulations, patient characteristics or differential diagnoses that are predictive of improved health outcomes in patients whose management is guided by the PET Aβ imaging?”
A total of 7,000 Medicare beneficiaries meeting specific inclusion criteria will be enrolled over 30 months at sites throughout the United States as part of a CMS Coverage with Evidence Development research program. Dementia specialists will team with trained radiologists and nuclear medicine physicians at PET facilities to order, conduct and interpret the amyloid PET; imaging results will be provided to the ordering physician for support in further decision making. As in the original study, the New IDEAS Study will include the use of three amyloid PET imaging radiopharmaceuticals that have been approved by the U.S. Food and Drug Administration for clinical use: F-18 florbetapir (Amyvid™), F-18 flutemetamol (Vizamyl™), and F-18 florbetaben (Neuraceq™).
The New IDEAS study, registered as ClinicalTrials.gov NCT04426539, has three specific aims:
The New IDEAS study will also have two additional objectives:
For more information of the New IDEAS Study, view the full protocol.
Costs related directly to the PET scan and radiopharmaceuticals will be covered by Medicare per Coverage with Evidence Development (CED) — like any other covered service. Patients or their supplemental Medicare insurance providers will be responsible for the applicable deductibles or co-payments.
CMS also provided advice and guidance over the course of planning and writing of the New IDEAS study protocol. CMS will also be represented on the New IDEAS study steering committee.
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 (CED) protocol in response to the CMS National Coverage Decision. The Alzheimer's Association identified and reconvened the IDEAS study leadership team and CMS to develop the New IDEAS study protocol. Alzheimer’s Association Chief Science Officer Maria Carrillo, PhD, 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, plus 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 for brain amyloid PET scans.
The American College of Radiology (ACR), founded in 1924, 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 New IDEAS Study. The ACR Center for Research and Innovation (CRI) is the clinical research centre of the ACR and has worked on the development of New IDEAS and writing of the protocol. The ACR will provide scientific leadership to the study, including study design, analysis and dissemination, and will provide ongoing oversight and decision making.