New Research Study To Demonstrate Value Of Brain PET Scans In Diagnosing Alzheimer's In Diverse Populations
The need for better tools to provide earlier and more accurate diagnosis of Alzheimer’s and other dementia is critical. The urgency is even higher with potential new treatments on the horizon, including the need for clinicians to demonstrate presence or absence of brain amyloid to make treatment decisions.
Building on the momentum of the IDEAS Study, the Alzheimer’s Association and the American College of Radiology, with manufacturing partners Eli Lilly and Co., GE Healthcare, and Life Molecular Imaging, have launched recruiting for the New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning study.
FDA-approved brain amyloid PET can detect one of the hallmark brain changes related to Alzheimer’s — amyloid accumulation — in those with mild cognitive impairment (MCI) or dementia of uncertain cause.
The goal of the New IDEAS study is to determine if using a brain amyloid PET scan helps clinicians provide a more accurate diagnosis and make better treatment decisions, which would then inform or change a patient’s treatment plan and improve their quality of life.
“The New IDEAS study aims to be among the most racially and ethnically diverse Alzheimer’s disease studies ever launched,” said Gil Rabinovici, M.D., Edward Fein and Pearl Landrith Distinguished Professor in Memory & Aging at UC San Francisco, and Principal Investigator of the New IDEAS Study. “New IDEAS study champions will actively conduct outreach and build relationships in Black/African American and Hispanic/Latino communities across the country.”
Medicare beneficiaries who meet clinical criteria for mild cognitive impairment (MCI) or dementia as defined by the 2018 National Institute on Aging – Alzheimer’s Association Research Framework (see also here) are eligible to participate via a referral from a participating dementia specialist. At least 4,000 of the planned 7,000 New IDEAS participants will be Black/African American and Hispanic/Latino, populations historically underrepresented in dementia research. Participants will be enrolled over 30 to 36 months at 350 sites throughout the United States.
“We hope that including racial and ethnic diversity will help us better understand the impact of amyloid PET scans on medical management and health outcomes in MCI and dementia cases in a diverse population — where we now have limited information. As treatment options advance in the pipeline, and the number of people with Alzheimer’s and other dementia continue to grow, we need to significantly advance our understanding of early detection and diagnosis, especially in underserved populations,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer.
“The New IDEAS study can help improve health equity by making Alzheimer’s research results more relevant across diverse populations. We strongly urge dementia specialists and PET imaging providers serving large, multicultural populations to actively take part in this important trial,” said American College of Radiology (ACR) Chief Science Officer Etta Pisano, MD, FACR.
Qualifying dementia specialists — physicians trained and board certified in neurology, psychiatry or geriatric medicine — collaborating with imaging facilities that offer amyloid positron emission tomography (PET) scans, can now enroll patients in the New IDEAS Study. More information about becoming a participating site can be found here.
Doctors not directly enrolling study participants are urged and welcomed to refer eligible patients to a New IDEAS participating physician for evaluation.
The Centers for Medicare & Medicaid Services (CMS) will reimburse participating dementia and imaging providers for care related to the brain amyloid PET scan through coverage with evidence development (CED).
Once enrolled in New IDEAS, eligible patients may get a brain amyloid PET scan. Participation in this study is currently the only way a brain amyloid PET scan is covered for Medicare beneficiaries. Medicare will reimburse for scans based on coverage plans. Annual deductibles and co-pays (up to 20%) will be the patient’s responsibility either through out of pocket or supplemental insurance. Coverage for patients enrolled in Medicare Advantage plans will vary.
The original IDEAS Study, with more than 18,000 participants, provided the strongest Phase IV data to date supporting the value of brain amyloid PET scans. IDEAS found that amyloid PET use changed patient management — including medications prescribed and referrals to counseling — in over 60% of cases, and altered diagnosis of the cause of cognitive impairment in more than one in three participants. Amyloid PET scan results also increased physician confidence in their diagnosis, and decreased other testing.
Expanding on the aims and scope of the original IDEAS Study, the New IDEAS study population will include: (1) more than 2,000 Hispanics/Latinos and 2,000 Blacks/African Americans, (2) people with typical and atypical clinical presentations of MCI and Alzheimer’s dementia, and (3) Medicare beneficiaries with early-onset cognitive impairment (before age 65). The new study will also collect blood and saliva samples for storage and analysis in the New IDEAS Biorepository. These will be used to test and validate emerging genetic and plasma biomarkers for Alzheimer’s and other dementia. Biomarkers can help identify who is most likely to benefit from Alzheimer’s treatments as they become available, and could also advance the testing of new experimental treatments.
The New IDEAS Study is led by the Alzheimer’s Association, managed by American College of Radiology, and advised by CMS. The study protocol for New IDEAS was approved by CMS in April 2020.