New IDEAS Study Protocol

New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study

NCT04426539 (ClinicalTrials.gov)

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Graphical schema of the New IDEAS Study
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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. 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.

Tailored recruitment strategies will be implemented to ensure inclusion of underrepresented populations including Black/African American patients, Latino/Hispanic patients, patients with early-onset (age < 65) cognitive impairment, and patients with typical or atypical presentation of MCI or dementia.

Dementia specialists will team with PET facilities that have trained radiologists/nuclear medicine physicians and access to perform amyloid PET. Amyloid PET will be performed and interpreted at each facility with results provided to the ordering physician 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 access to amyloid PET at the “pre-PET visit.” PET results will be disclosed to participants and changes in management 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, 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.

FAQ

The New IDEAS Study: Imaging Dementia—Evidence for Amyloid Scanning is a Coverage with Evidence Development (CED) study approved by CMS. The New IDEAS study builds upon the original IDEAS study completed in early 2018 which was an unprecedented collaborative study to demonstrate the value of amyloid PET scans in Alzheimer’s Disease diagnosis. New IDEAS will address additional gaps in knowledge that are highly relevant to improve precision in future coverage decisions and implementation of amyloid PET in clinical practice.

The New IDEAS study differs from the original study by:

  • Sample size — New IDEAS has 7,000 (compared with approximately 18,000 in IDEAS, the largest Alzheimer’s disease study).
  • Increased focus on recruitment of underrepresented minority populations.
  • Includes early-onset and typical clinical presentations of Alzheimer’s disease.
  • ApoE genotyping via saliva collection.
  • Optional blood collection to establish a biorepository.
Enrollment is expected to begin in Q4 of 2020 and runs through Q1 2023, provided there are no delays as a result of the global COVID-19 pandemic.

The New IDEAS study is a CMS Coverage with Evidence Development (CED) study and is designed to be analogous to routine care. Paying enrollees' out-of-pocket costs for an FDA-approved and clinically available procedure would not be consistent with routine care.

 

Per cms.gov:

  • CED is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data.
  • A CED cycle is considered “completed” when CMS removes a requirement for study participation as a condition of coverage for one or more indications of an item or service.

The New IDEAS study will provide additional data to allow CMS to complete the CED cycle. This may result in Medicare coverage for a brain amyloid PET scan for all eligible Medicare beneficiaries. Once the CED cycle is complete, Medicare coverage, as in the New IDEAS Study, would continue to be subject to individuals’ benefits per their insurance plan(s).

 

For more information about CED see the CMS website.

Compared to the original IDEAS study, the New IDEAS study has a goal of ensuring that patients living in underserved communities are included in Alzheimer’s disease research. Strategic awareness-raising and tailored recruitment strategies led by team investigators who are experts in community-engagement approaches and research methods will support participation of racial and ethnic minority communities in New IDEAS. Key factors in the recruitment will include the research team partnering with community members and healthcare providers in select metropolitan areas to encourage Black/African American and Latinx participation.

The New IDEAS study team will enroll 7,000 Medicare beneficiaries across the United States to kick off the study. Enrollment will include 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 to specifically address the dearth of racially and ethnically diverse research participants in Alzheimer’s disease clinical research.

Among the participants enrolled in New IDEAS, individuals with early-onset dementia (<65 years of age) will be included for analysis, as well as individuals of both typical or atypical clinical presentations of mild cognitive impairment and dementia. New IDEAS will also collect biological samples such as saliva and blood to be stored in a New IDEAS biorepository. New IDEAS researchers and others will use these samples to test and validate emerging genetic and plasma biomarkers for Alzheimer’s disease and all other dementia from an early and accurate diagnosis.

Finally, beyond amyloid PET, there are many additional biomarkers in development for Alzheimer’s disease and other causes of dementia. Results from the New IDEAS study will help create precedent and lay the groundwork for the type of information that regulators will need when considering coverage for future biomarkers.

That is for CMS to decide. The New IDEAS study leadership has taken several well-considered steps in order to ensure meaningful study results in this regard. These include:

  • Both studies have been modeled after the largest successful Coverage with Evidence Development (CED) study. The National Oncologic PET Registry (NOPR) collected data to assess the effect of PET on management of over 300,000 Medicare beneficiaries with cancer and afforded broad access to Medicare reimbursement for these patients.
  • Both studies are sufficiently powered to demonstrate changes in health outcomes and patient care management as a result of knowing the results of a brain amyloid PET scan.
The New IDEAS study’s Biostatistics and Data Management Center will monitor participant accrual and data submission. The organizational structure is modeled after other successful studies of this type and attempts to provide the optimal balance between tight control and broad engagement. The combination of a steering committee (with associated subcommittees) and operations center creates an effective structure that will promote rapid completion of the study while ensuring maximum data integrity. Quality assurance procedures for amyloid PET interpretation will include vendor-specific training programs. Vendors will have expert consultants available to local readers for cases that might require additional assistance in interpretation.

Study participants must be Medicare beneficiaries, with Medicare as their primary health insurance, be referred by a qualified dementia specialist, and must fit the following basic inclusion criteria:

  • Meet 2018 NIA-AA criteria for MCI or dementia.
  • Meet criteria for “clinically typical” or “clinically atypical” presentation of Alzheimer’s disease.

See full inclusion and exclusion criteria for participation in New IDEAS.

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 Black/African Americans participants, at least 2,000 Latinx/Hispanic participants, and up to 3,000 additional participants from other racial and ethnic backgrounds.

Yes. As excerpted from the patient consent:

“If you join the study, your amyloid PET scan will be paid for by Medicare as a covered benefit under the Coverage with Evidence Development (CED) program. As with any medical service covered by Medicare, you will still be responsible for any deductible or co-payment required for the service. The amount you would have to pay will depend on whether or not you have supplemental insurance or other coverage for your deductible and co-payments. Your visits to your doctor will also be billed to your applicable insurances with the same responsibility of deductible or co-payment of the service.”

There is no mechanism in place to allow for coverage of the co-pay.

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