An observational study in Alzheimer's Disease, Dementia and Mild Cognitive Impairment, sponsored by American College of Radiology. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by American College of Radiology · Observational
New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.
A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will be consented 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/nuclear medicine physicians and access to perform amyloid PET. All participating physicians and study staff will complete comprehensive training to ensure adherence of data requirements and study timelines. Amyloid PET will be performed and interpreted at each facility with results provided to the ordering dementia specialist for support in further decision making. The dementia specialists will record their diagnosis and intended management plan based on the current clinical and diagnostic information, and assuming no future access to amyloid PET at the "Pre-PET visit." This represents a "thought experiment" documenting the management plan that would be recommended by the specialist if the participant were not enrolling in New IDEAS and thus had no access to amyloid PET. PET results will be disclosed to patients and any 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." At this final visit, the dementia specialists will record the diagnosis and implemented management 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 months after the 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 entire cohort. Aims 2 and 3 investigate these associations in sub-groups of study participants based on self-identified race and ethnicity (Aim 2) and clinical presentation (Aim 3). Aims 2 and 3 additionally evaluate changes in management between the pre- and post-PET visits in the relevant sub-groups, to test whether benefits in health outcomes are mediated by changes in clinical management. The investigator's over-arching hypothesis, supported by preliminary data from the first IDEAS study, is that amyloid PET results will be associated with changes in clinical management, which in turn will translate into improved health outcomes in patients with 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, enabling the testing and validation of emerging genetic and blood biomarkers. Separate consent will be obtained for participation in these components.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 6,061 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →American College of Radiology is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will be consented 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.
Exclusion Criteria:
Those for whom a beta amyloid PET scan is consistent with underlying AD as causing or contributing to cognitive impairment
Those for whom a beta amyloid PET scan has ruled out AD (i.e. not consistent with underlying AD as causing or contributing to cognitive impairment)
Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative
To compare 12-month claims-derived health outcomes in amyloid PET-positive versus amyloid PET-negative individuals presenting with MCI and dementia in the entire study cohort of diverse Medicare beneficiaries.
Time frame: 12 Months
Aim 2: Changes in patient management and health outcomes among various ethnoracial groups
To describe the association of amyloid PET findings with changes in patient management and 12-month claims-derived health outcomes among Blacks/African Americans, Latinos/Hispanics and Whites/Caucasians presenting with MCI and dementia.
Time frame: 12 Months
Aim 3: Changes in patient management and health outcomes among various clinical presentations
To describe the association of amyloid PET findings with changes in management and 12-month claims-derived health outcomes in individuals presenting with typical (progressive amnestic) versus atypical clinical presentations of MCI and AD dementia.
Time frame: 12 Months
Plan to share: Yes — The Study is committed to providing investigators in academia and industry an opportunity to access data collected as part of the study for purposes that are consistent with the goals of New IDEAS. The IDEAS Study archives the clinical and image data obtained as part of its research activity. This archive can be used for secondary research studies, to guide further technology development, and for educational purposes. Access to CMS claims data used in the New IDEAS Study is handled separately and requires permission from CMS. Any individual or entity may submit a request for the clinical data, image data, or images linked to clinical data archived by the New IDEAS Study. The Study will provide requesters the raw data as it is archived in the database. However, requesters can specify subsets of data they desire using the annotated elements from the case report forms. The identity (and identifiable information) of trial participants, sites and Study investigators will not be provided.
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American College of Radiology