FTS‐04‐02: Imaging dementia: Evidence for amyloid scanning (IDEAS)—a national study to evaluate the clinical utility of amyloid PET
Year: 2015
Type: article
Study design: Study Protocol
Abstract: In its 2013 National Coverage Decision on amyloid-beta PET imaging, the U.S. Centers for Medicare & Medicaid Services (CMS) indicated that one-time reimbursement would be considered under coverage with evidence development (CED) as part of research studies to evaluate the scan's impact on patient-oriented outcomes. A national CED protocol for amyloid PET was developed in response to the CMS decision. The protocol was written under the sponsorship of the Alzheimer's Association and in partnership with the American College of Radiology and the Society for Nuclear Medicine and Molecular Imaging. Key input on the protocol was provided by thought leaders in amyloid PET, CMS and industry stakeholders. Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) is an open-label, longitudinal cohort study to assess the impact of amyloid PET in patients meeting Appropriate Use Criteria (AUC) for amyloid imaging (Johnson et al. 2013). The primary hypothesis is that in diagnostically uncertain cases of MCI and atypical dementia, knowledge of amyloid status will lead to significant changes in patient management, and this will translate into improved medical outcomes. Approximately 18,500 Medicare beneficiaries will be enrolled in a registry from sites across the U.S. Participants will be selected by dementia experts in partnership with PET facilities certified to perform and interpret amyloid PET. Aim 1 investigates the impact of amyloid PET on short-term patient management (90 days after the scan) in a cumulative endpoint consisting of: AD drug therapy, other drug therapy, and counselling about safety and future planning. Aim 2 utilizes Medicare claims data to construct a matched control group of amyloid PET naïve patients and compare 12-month rates of hospitalization and emergency room visits between registry and control Outcomes in both aims will be assessed separately in MCI and dementia. The study will further investigate how the scan impacts health care resource utilization. IDEAS was approved by CMS in April 2015, and aims to launch enrollment in early 2016 and complete analysis in 2020. The IDEAS cohort can serve as a foundation for developing further studies in this population.
Source: Alzheimer s & Dementia
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2336207976