<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426539</url>
  </required_header>
  <id_info>
    <org_study_id>New IDEAS</org_study_id>
    <nct_id>NCT04426539</nct_id>
  </id_info>
  <brief_title>New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study</brief_title>
  <official_title>New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American College of Radiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alzheimer's Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>American College of Radiology</source>
  <brief_summary>
    <textblock>
      New IDEAS is an observational, open-label, longitudinal cohort study designed to address the&#xD;
      requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial&#xD;
      Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the&#xD;
      association between amyloid PET and patient-centered outcomes in an expanded and more&#xD;
      ethnoracially and clinically diverse group of Medicare participants presenting with cognitive&#xD;
      impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will be&#xD;
      consented and enrolled over 30 months at sites throughout the United States. To ensure&#xD;
      diversity, the study will enroll at least 2,000 Blacks/African Americans, at least 2,000&#xD;
      Latinos/Hispanics, and up to 3,000 additional participants from other racial and ethnic&#xD;
      backgrounds. Based on disease stage prior to PET, all participants will be classified as&#xD;
      having MCI or dementia as their disease stage. Based on their clinical presentation prior to&#xD;
      PET, all participants will be classified as having &quot;typical&quot; (i.e. progressive amnestic) or&#xD;
      &quot;atypical&quot; clinical presentations of AD as the potential cause of dementia or MCI.&#xD;
&#xD;
      Dementia specialists will team with PET facilities that have trained radiologists/nuclear&#xD;
      medicine physicians and access to perform amyloid PET. All participating physicians and study&#xD;
      staff will complete comprehensive training to ensure adherence of data requirements and study&#xD;
      timelines. Amyloid PET will be performed and interpreted at each facility with results&#xD;
      provided to the ordering dementia specialist for support in further decision making. The&#xD;
      dementia specialists will record their diagnosis and intended management plan based on the&#xD;
      current clinical and diagnostic information, and assuming no future access to amyloid PET at&#xD;
      the &quot;Pre-PET visit.&quot; This represents a &quot;thought experiment&quot; documenting the management plan&#xD;
      that would be recommended by the specialist if the participant were not enrolling in New&#xD;
      IDEAS and thus had no access to amyloid PET. PET results will be disclosed to patients and&#xD;
      any consequent changes in management (if any) will be recommended at the &quot;PET disclosure&#xD;
      visit.&quot; Patients will return 90 ± 30 days following PET for an in person &quot;Post-PET visit.&quot; At&#xD;
      this final visit, the dementia specialists will record the diagnosis and implemented&#xD;
      management plan, incorporating amyloid PET into clinical decision making. Medicare claims&#xD;
      data will be collected directly from CMS for 12 months prior to the PET imaging and 12 months&#xD;
      after the PET imaging, for each participant.&#xD;
&#xD;
      Aim 1 utilizes Medicare claims data to compare 12-month claims-derived outcomes in amyloid&#xD;
      PET-positive versus amyloid PET-negative individuals with MCI and dementia across the entire&#xD;
      cohort. Aims 2 and 3 investigate these associations in sub-groups of study participants based&#xD;
      on self-identified race and ethnicity (Aim 2) and clinical presentation (Aim 3). Aims 2 and 3&#xD;
      additionally evaluate changes in management between the pre- and post-PET visits in the&#xD;
      relevant sub-groups, to test whether benefits in health outcomes are mediated by changes in&#xD;
      clinical management. The investigator's over-arching hypothesis, supported by preliminary&#xD;
      data from the first IDEAS study, is that amyloid PET results will be associated with changes&#xD;
      in clinical management, which in turn will translate into improved health outcomes in&#xD;
      patients with amyloid PET-positive scans in comparison with patients with amyloid&#xD;
      PET-negative scans. We further hypothesize that these effects will be seen across patients of&#xD;
      different ethnoracial backgrounds, clinical presentations and disease stages (MCI and&#xD;
      dementia).&#xD;
&#xD;
      Optional components of the study include the collection and archival of participant's amyloid&#xD;
      PET images, and blood plasma. These repositories will serve as a resource to the field,&#xD;
      enabling the testing and validation of emerging genetic and blood biomarkers. Separate&#xD;
      consent will be obtained for participation in these components.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative</measure>
    <time_frame>12 Months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aim 2: Changes in patient management and health outcomes among various ethnoracial groups</measure>
    <time_frame>12 Months</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Aim 3: Changes in patient management and health outcomes among various clinical presentations</measure>
    <time_frame>12 Months</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">7000</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Dementia</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Amyloid PET-Positive</arm_group_label>
    <description>Those for whom a beta amyloid PET scan is consistent with underlying AD as causing or contributing to cognitive impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amyloid PET-Negative</arm_group_label>
    <description>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)</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva will be collected from all study participants for DNA analysis. After analysis, saliva&#xD;
      samples will be destroyed. Plasma and DNA will be extracted from whole blood samples, and&#xD;
      stored for future research, from those participants who specifically consent to blood&#xD;
      collection.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will be&#xD;
        consented and enrolled over 30 months at sites throughout the United States. To ensure&#xD;
        diversity, the study will enroll at least 2,000 Blacks/African Americans, at least 2,000&#xD;
        Latinos/Hispanics, and up to 3,000 additional participants from other racial and ethnic&#xD;
        backgrounds. Based on disease stage prior to PET, all participants will be classified as&#xD;
        having MCI or dementia as their disease stage. Based on their clinical presentation prior&#xD;
        to PET, all participants will be classified as having &quot;typical&quot; (i.e. progressive amnestic)&#xD;
        or &quot;atypical&quot; clinical presentations of AD as the potential cause of dementia or MCI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medicare beneficiary with Medicare as primary insurance;&#xD;
&#xD;
          -  Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by&#xD;
             the 2018 National Institute on Aging - Alzheimer's Association Research Framework&#xD;
&#xD;
          -  Brain MRI and/or CT within 24 months prior to enrollment;&#xD;
&#xD;
          -  Clinical laboratory assessment (complete blood count [CBC], standard blood chemistry&#xD;
             profile, thyroid stimulating hormone [TSH], vitamin B12) within the 12 months prior to&#xD;
             enrollment;&#xD;
&#xD;
          -  Able to tolerate amyloid PET required by protocol, to be performed at a participating&#xD;
             PET facility;&#xD;
&#xD;
          -  English or Spanish speaking (for the purposes of informed consent);&#xD;
&#xD;
          -  Willing and able to provide consent. Consent may be by proxy;&#xD;
&#xD;
          -  Neuropsychiatric syndrome can be classified into &quot;clinically typical&quot; or &quot;clinically&#xD;
             atypical&quot; categories&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Normal cognition or subjective complaints that are not verified by cognitive testing&#xD;
             or key informant.&#xD;
&#xD;
          -  Knowledge of amyloid status, in the opinion of the referring dementia expert, may&#xD;
             cause significant psychological harm or otherwise negatively impact the patient or&#xD;
             family.&#xD;
&#xD;
          -  Amyloid status already known to patient or referring clinician based on prior amyloid&#xD;
             imaging or cerebrospinal fluid analysis.&#xD;
&#xD;
          -  Current or previous enrollment in an anti-amyloid therapeutic trial.&#xD;
&#xD;
          -  Scan is being ordered solely based on a family history of dementia, presence of&#xD;
             apolipoprotein E (ApoE) 4, or in lieu of genotyping for suspected autosomal mutation&#xD;
             carriers.&#xD;
&#xD;
          -  Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or&#xD;
             employment screening).&#xD;
&#xD;
          -  Cancer requiring active therapy (excluding non-melanoma skin cancer).&#xD;
&#xD;
          -  Hip/pelvic fracture within the 12 months prior to enrollment.&#xD;
&#xD;
          -  Body weight exceeds PET scanner weight limit.&#xD;
&#xD;
          -  Currently pregnant or planning to become pregnant within 90 days of registration.&#xD;
&#xD;
          -  Life expectancy less than 24 months based on medical co-morbidities.&#xD;
&#xD;
          -  Residence in a skilled nursing facility (assisted living facility is not an exclusion&#xD;
             criterion).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil Rabinovici, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>New IDEAS Study Team</last_name>
    <phone>215-574-3229</phone>
    <email>ideas-study@acr.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Full list of Active Sites and Imaging Facilities</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Go to Site Finder Website at https://www.ideas-study.org/Find-a-Site</last_name>
      <phone>866-507-7254</phone>
      <email>newideas-participant@alz.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ideas-study.org/</url>
    <description>Main Study Website</description>
  </link>
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  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
    <ipd_time_frame>Study data and images ordinarily will not be released to individuals or companies prior to the publication of the trial's primary aim manuscripts</ipd_time_frame>
    <ipd_access_criteria>The application forms for requesting archived clinical and image data is available on the IDEAS Study Web site. Requests for access to the IDEAS Study archive should be sent to IDEASResearchPub@acr.org. In the case of independent researchers or corporations, requests should be of a research or educational nature or for purposes of technology development. Before indicating in a grant proposal that clinical and/or image data archived by IDEAS Study will be used to conduct the proposed research, an investigator should submit a request and obtain written approval from IDEAS Study prior to submitting the grant proposal. IDEAS Study treats such requests as it does any other.</ipd_access_criteria>
    <ipd_url>https://www.ideas-study.org/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426539
org study id: New IDEAS
nct id: NCT04426539
lead sponsor: 
collaborator: 
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.
observational model: Cohort
time perspective: Prospective
measure: Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative
time frame: 12 Months
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.
measure: Aim 2: Changes in patient management and health outcomes among various ethnoracial groups
time frame: 12 Months
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.
measure: Aim 3: Changes in patient management and health outcomes among various clinical presentations
time frame: 12 Months
description: 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.
arm group label: Amyloid PET-Positive
description: Those for whom a beta amyloid PET scan is consistent with underlying AD as causing or contributing to cognitive impairment
arm group label: Amyloid PET-Negative
description: 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)
Saliva will be collected from all study participants for DNA analysis. After analysis, saliva
      samples will be destroyed. Plasma and DNA will be extracted from whole blood samples, and
      stored for future research, from those participants who specifically consent to blood
      collection.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gil Rabinovici, MD
role: Study Chair
affiliation: University of California, San Francisco
last name: New IDEAS Study Team
phone: 215-574-3229
email: ideas-study@acr.org
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.ideas-study.org/
description: Main Study Website
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responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: 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.
ipd time frame: Study data and images ordinarily will not be released to individuals or companies prior to the publication of the trial's primary aim manuscripts
ipd access criteria: The application forms for requesting archived clinical and image data is available on the IDEAS Study Web site. Requests for access to the IDEAS Study archive should be sent to IDEASResearchPub@acr.org. In the case of independent researchers or corporations, requests should be of a research or educational nature or for purposes of technology development. Before indicating in a grant proposal that clinical and/or image data archived by IDEAS Study will be used to conduct the proposed research, an investigator should submit a request and obtain written approval from IDEAS Study prior to submitting the grant proposal. IDEAS Study treats such requests as it does any other.
ipd url: https://www.ideas-study.org/