Brief Summary
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.
Brief Title
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
Detailed Description
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
215-574-3229
Central Contact Email
ideas-study@acr.org
Completion Date
Completion Date Type
Estimated
Conditions
Alzheimer's Disease
Dementia
Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
* Medicare beneficiary with Medicare as primary insurance;
* Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework
* Brain MRI and/or CT within 24 months prior to enrollment;
* Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment;
* Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
* English or Spanish speaking (for the purposes of informed consent);
* Willing and able to provide consent. Consent may be by proxy;
* Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories
Exclusion Criteria:
* Normal cognition or subjective complaints that are not verified by cognitive testing or key informant.
* Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
* Amyloid status already known to patient or referring clinician based on prior amyloid imaging or cerebrospinal fluid analysis.
* Current or previous enrollment in an anti-amyloid therapeutic trial.
* Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E (ApoE) 4, or in lieu of genotyping for suspected autosomal mutation carriers.
* Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
* Cancer requiring active therapy (excluding non-melanoma skin cancer).
* Hip/pelvic fracture within the 12 months prior to enrollment.
* Body weight exceeds PET scanner weight limit.
* Currently pregnant or planning to become pregnant within 90 days of registration.
* Life expectancy less than 24 months based on medical co-morbidities.
* Residence in a skilled nursing facility (assisted living facility is not an exclusion criterion).
* Medicare beneficiary with Medicare as primary insurance;
* Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework
* Brain MRI and/or CT within 24 months prior to enrollment;
* Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment;
* Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
* English or Spanish speaking (for the purposes of informed consent);
* Willing and able to provide consent. Consent may be by proxy;
* Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories
Exclusion Criteria:
* Normal cognition or subjective complaints that are not verified by cognitive testing or key informant.
* Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
* Amyloid status already known to patient or referring clinician based on prior amyloid imaging or cerebrospinal fluid analysis.
* Current or previous enrollment in an anti-amyloid therapeutic trial.
* Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E (ApoE) 4, or in lieu of genotyping for suspected autosomal mutation carriers.
* Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
* Cancer requiring active therapy (excluding non-melanoma skin cancer).
* Hip/pelvic fracture within the 12 months prior to enrollment.
* Body weight exceeds PET scanner weight limit.
* Currently pregnant or planning to become pregnant within 90 days of registration.
* Life expectancy less than 24 months based on medical co-morbidities.
* Residence in a skilled nursing facility (assisted living facility is not an exclusion criterion).
Inclusion Criteria
Inclusion Criteria:
* Medicare beneficiary with Medicare as primary insurance;
* Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework
* Brain MRI and/or CT within 24 months prior to enrollment;
* Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment;
* Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
* English or Spanish speaking (for the purposes of informed consent);
* Willing and able to provide consent. Consent may be by proxy;
* Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories
* Medicare beneficiary with Medicare as primary insurance;
* Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework
* Brain MRI and/or CT within 24 months prior to enrollment;
* Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment;
* Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
* English or Spanish speaking (for the purposes of informed consent);
* Willing and able to provide consent. Consent may be by proxy;
* Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04426539
Org Class
Other
Org Full Name
American College of Radiology
Org Study Id
New IDEAS
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
Primary Outcomes
Outcome Description
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.
Outcome Measure
Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative
Outcome Time Frame
12 Months
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
12 Months
Outcome Measure
Aim 2: Changes in patient management and health outcomes among various ethnoracial groups
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jessica Zwerling
Investigator Email
jzwerlin@montefiore.org