The Imaging Dementia — Evidence for Amyloid Scanning (IDEAS) Study will assess the clinical usefulness and impact on patient-oriented outcomes of a brain positron emission tomography (PET) scan that detects amyloid plaques, a core feature of Alzheimer’s disease, in patients with mild cognitive impairment (MCI) or dementia of uncertain cause.
A total of 18,488 Medicare beneficiaries meeting specific appropriate use criteria (AUC) will be enrolled over 24 months at sites throughout the United States as part of a Centers for Medicare & Medicaid Services (CMS) Coverage with Evidence Development (CED) research program. Dementia specialists will team with trained radiologists and nuclear medicine physicians at PET facilities to order, conduct, and interpret the amyloid PET; imaging results will be provided to the ordering physician for support in further decision making.
The IDEAS Study will include the three amyloid PET imaging radiopharmaceuticals that have been approved by the U.S. Food and Drug Administration for clinical use: F-18 florbetapir (Amyvid™), F-18 flutemetamol (Vizamyl™), and F-18 florbetaben (Neuraceq™).
The IDEAS Study, registered as Clinical Trials NCT02420756, will address two specific aims:
- Assess the impact of amyloid PET on the management of patients meeting AUC
- Assess the impact of amyloid PET over 12 months on major medical outcomes such as hospital admissions and emergency room visits in patients enrolled in the study compared to matched patients not in the study
Aim 1 investigates the impact of amyloid PET on short-term patient management by comparing pre-PET intended management to post-PET actual management recorded 90 days after the scan by the referring physician. Examples of changes in management include: use of Alzheimer’s drug therapy, other drug therapy, and counseling about safety and future planning.
Aim 2 utilizes Medicare claims data to compare medical outcomes at 12 months for patients enrolled in the study with a matched control cohort of patients who have never undergone amyloid PET imaging. The primary objective will be to determine if amyloid PET testing in the amyloid PET-known cohort of patients is associated with a significant reduction in major medical outcomes, including hospitalizations and emergency room visits. The study will also investigate how the scans impact use of health care resources and services.
The IDEAS Study is led by the Alzheimer’s Association and the American College of Radiology Imaging Network (ACRIN®) and managed by the American College of Radiology (ACR®). We gratefully acknowledge the contributions of our industry partners — as well as our collaborators from the Society for Nuclear Medicine and Molecular Imaging and the Medical Imaging and Technology Alliance.