New IDEAS (Imaging Dementia-Evidence for Amyloid Scanning) Study
Background
New IDEAS will align with the Center for Medicare and Medicaid Services’ (CMS)National Coverage Determination (NCD) stated clinical objectives to (1) “develop better treatment and prevention strategies for AD” patients, those who are most likely to develop AD, and for those for whom Alzheimer’s disease (AD)has been excluded. The study will also identify subpopulations at risk for AD, and (2) “resolve clinically difficult differential diagnoses. ”We will follow and compare two cohorts of patients: those for whom a beta amyloid PET scan is consistent with underlying ADas causing or contributing to cognitive impairment, and those for whom the scan has ruled out AD, to determine if beta-amyloid PET imaging has affected patient health outcomes, including short term outcomes related to changes in management and longer term dementia outcomes. In addition, New IDEAS will concentrate on the recruitment of Blacks/African Americans and Latinx/Hispanics, as well as Medicare beneficiaries with early-onset (age < 65) cognitive impairment. New IDEAS will evaluate and compare changes in management and CMS claims-derived health outcomes in amyloid PET-positive versus amyloid PET-negative individuals in a diverse sample of patients with mild cognitive impairment (MCI)and dementia. The study adds saliva collection for genotyping of ApoE, an important risk factor for brain amyloidosis, in all participants. Additional objectives of the study are to establish a biorepository of plasma and DNA samples and to archive PET images from study participants who consent to these optional elements.
Objective
The over-arching goal of the New IDEAS Study is to evaluate the utility of beta-amyloid PET to “exclude Alzheimer’s disease (AD) in narrowly defined and clinically difficult differential diagnoses” in a broad and diverse population of Medicare beneficiaries with cognitive impairment, as described in CMS’ Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.
Study Team/Roles
- Peggye Dilworth-Anderson, Ph.D.: PI
- Shikira Flounory, MSPH: Research Program Manager
- Andrea Mendoza, MPH: Community Engagement Specialist
Partnerships
- Directed by: Alzheimer’s Association
- Sponsored and Managed by: American College of Radiology
- Advised by: Centers for Medicare & Medicaid Services (CMS) Study Team