New IDEAS, a follow-up study to the pioneering IDEAS study (Imaging Dementia: Evidence for Amyloid Scanning), has begun recruiting patients, with a goal of recruiting more than 50% of whom self-identify as Black/African American and Hispanic/Latinx — populations that were underrepresented in the original study. The goal of New IDEAS, sponsored and managed by the ACR and in partnership with the Alzheimer’s Association, is to determine whether using a brain amyloid PET scan helps clinicians provide a more accurate diagnosis and make better treatment decisions for patients with Alzheimer’s disease and other types of dementia. In addition to a focus on recruiting minority populations, the study is collecting saliva and blood samples to validate and test emerging genetic and plasma biomarkers for Alzheimer’s and other types of dementia.
“The New IDEAS study aims to be among the most racially and ethnically diverse Alzheimer’s disease studies ever launched,” says Gil D. Rabinovici, MD, the Edward Fein and Pearl Landrith Distinguished Professor in Memory and Aging at the University of California San Francisco and principal investigator of the New IDEAS study. “The study champions will actively conduct outreach and build relationships in Black/African American and Hispanic/Latinx communities across the country.”
Building on IDEAS
The first IDEAS study of more than 16,000 Medicare beneficiaries demonstrated that using amyloid PET as part of the diagnostic process had a significant impact on patient management in people with mild cognitive impairment or dementia in which the cause was uncertain. In an analysis of more than 11,000 participants, patient management after amyloid PET changed in 60.2% of patients with mild cognitive impairment and in 63.5% of patients with dementia. Further research is needed to determine if amyloid PET is associated with improved clinical outcomes.1
Working With CMS
Brain amyloid PET can detect one of the hallmark brain changes related to Alzheimer’s — amyloid plaque accumulation — in those with mild cognitive impairment or dementia of uncertain cause. Although such scans are FDA-approved, they are not yet covered by CMS, as determined by the 2013 National Coverage Determination on Beta Amyloid PET in Dementia and Neurodegenerative Disease. Therefore, the ACR, the Alzheimer’s Association, and the New IDEAS study team worked closely with CMS to fulfill the agency’s requirements for reimbursement of the study participants’ amyloid PET scans under its Coverage for Evidence Development provision. In addition to the Alzheimer’s Association, ACR is partnering with Eli Lilly and Co., GE Healthcare, and Life Molecular Imaging — which manufacture FDA-approved beta amyloid PET radiotracers.
The study champions will actively conduct outreach and build relationships in Black/African American and Hispanic/Latinx communities across the country.
Focusing on Diversity
A limitation of the original IDEAS study cohort was a lack of racial and ethnic diversity, with 88% of participants identifying as non-Hispanic/Latinx White. This likely reflects discrepancies in minority access to specialist care, as well as the need for tailored approaches to successfully recruit minority populations into research studies. The new study will focus on community recruitment to connect with patients in both clinical and non-clinical settings.
Strategic awareness-raising and tailored recruitment strategies will be led by teams from Vanderbilt University Medical Center and the University of North Carolina, with track records in community- engagement approaches and research methods in minority and diverse communities.