New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will bed and enrolled over 30 months at sites throughout the United States. To ensure diversity, the study will enroll at least 2,000 Blacks/African Americans, at least 2,000 Latinos/Hispanics, and up to 3,000 additional participants from other racial and ethnic backgrounds. Based on disease stage prior to PET, all participants will be classified as having MCI or dementia as their disease stage. Based on their clinical presentation prior to PET, all participants will be classified as having "typical" (i.e. progressive amnestic) or "atypical" clinical presentations of AD as the potential cause of dementia or MCI.

Dementia specialists will team with PET facilities that have trained radiologists/nucleardicine physicians and access to perform amyloid PET. All participating physicians and studywill complete comprehensive training to ensure adherence of data requirements and study. Amyloid PET will be performed and interpreted at each facility with resultsvided to the ordering dementia specialist for support in further decision making. The dementia specialists will record their diagnosis and intended management plan based on theurrent clinical and diagnostic information, and assuming no future access to amyloid PET athe "Pre-PET visit." This represents a "thought experiment" documenting the management planhat would be recommended by the specialist if the participant were not enrolling in NewDEAS and thus had no access to amyloid PET. PET results will be disclosed to patients andy consequent changes in management (if any) will be recommended at the "PET disclosure visit." Patients will return 90 ± 30 days following PET for an in person "Post-PET visit." Athis final visit, the dementia specialists will record the diagnosis and implementedgement plan, incorporating amyloid PET into clinical decision making. Medicare claims data will be collected directly from CMS for 12 months prior to the PET imaging and 12 monthshe PET imaging, for each participant.

Aim 1 utilizes Medicare claims data to compare 12-month claims-derived outcomes in amyloid PET-positive versus amyloid PET-negative individuals with MCI and dementia across the entirehort. Aims 2 and 3 investigate these associations in sub-groups of study participants baseddentified race and ethnicity (Aim 2) and clinical presentation (Aim 3). Aims 2 and 3dditionally evaluate changes in management between the pre- and post-PET visits in thevant sub-groups, to test whether benefits in health outcomes are mediated by changes ingement. The investigator's over-arching hypothesis, supported by preliminary data from the first IDEAS study, is that amyloid PET results will be associated with changesgement, which in turn will translate into improved health outcomes inwith amyloid PET-positive scans in comparison with patients with amyloid PET-negative scans. We further hypothesize that these effects will be seen across patients of different ethnoracial backgrounds, clinical presentations and disease stages (MCI and dementia).

Optional components of the study include the collection and archival of participant's amyloid PET images, and blood plasma. These repositories will serve as a resource to the field,bling the testing and validation of emerging genetic and blood biomarkers. Separatewill be obtained for participation in these components.