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New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

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ClinicalTrials.gov Identifier: NCT04426539
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : December 31, 2020
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
American College of Radiology

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.

Condition or disease
Alzheimer's Disease Dementia Mild Cognitive Impairment

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Group/Cohort
Amyloid PET-Positive
Those for whom a beta amyloid PET scan is consistent with underlying AD as causing or contributing to cognitive impairment
Amyloid PET-Negative
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)



Primary Outcome Measures :
  1. Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative [ Time Frame: 12 Months ]
    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.


Secondary Outcome Measures :
  1. Aim 2: Changes in patient management and health outcomes among various ethnoracial groups [ Time Frame: 12 Months ]
    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.


Other Outcome Measures:
  1. Aim 3: Changes in patient management and health outcomes among various clinical presentations [ Time Frame: 12 Months ]
    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.


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426539


Contacts
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Contact: New IDEAS Study Team 215-574-3229 ideas-study@acr.org

Locations
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United States, Maryland
Neurological Medicine, PA Recruiting
Greenbelt, Maryland, United States, 20770
Contact: Hassan Hussain, MD    301-982-7944    info@neuromedpa.com   
Sponsors and Collaborators
American College of Radiology
Alzheimer's Association
Investigators
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Study Chair: Gil Rabinovici, MD University of California, San Francisco
Additional Information:
Publications:
Jansen WJ, Ossenkoppele R, Tijms BM, Fagan AM, Hansson O, Klunk WE, van der Flier WM, Villemagne VL, Frisoni GB, Fleisher AS, Lleó A, Mintun MA, Wallin A, Engelborghs S, Na DL, Chételat G, Molinuevo JL, Landau SM, Mattsson N, Kornhuber J, Sabri O, Rowe CC, Parnetti L, Popp J, Fladby T, Jagust WJ, Aalten P, Lee DY, Vandenberghe R, Resende de Oliveira C, Kapaki E, Froelich L, Ivanoiu A, Gabryelewicz T, Verbeek MM, Sanchez-Juan P, Hildebrandt H, Camus V, Zboch M, Brooks DJ, Drzezga A, Rinne JO, Newberg A, de Mendonça A, Sarazin M, Rabinovici GD, Madsen K, Kramberger MG, Nordberg A, Mok V, Mroczko B, Wolk DA, Meyer PT, Tsolaki M, Scheltens P, Verhey FRJ, Visser PJ; Amyloid Biomarker Study Group, Aarsland D, Alcolea D, Alexander M, Almdahl IS, Arnold SE, Baldeiras I, Barthel H, van Berckel BNM, Blennow K, van Buchem MA, Cavedo E, Chen K, Chipi E, Cohen AD, Förster S, Fortea J, Frederiksen KS, Freund-Levi Y, Gkatzima O, Gordon MF, Grimmer T, Hampel H, Hausner L, Hellwig S, Herukka SK, Johannsen P, Klimkowicz-Mrowiec A, Köhler S, Koglin N, van Laere K, de Leon M, Lisetti V, Maier W, Marcusson J, Meulenbroek O, Møllergård HM, Morris JC, Nordlund A, Novak GP, Paraskevas GP, Perera G, Peters O, Ramakers IHGB, Rami L, Rodríguez-Rodríguez E, Roe CM, Rot U, Rüther E, Santana I, Schröder J, Seo SW, Soininen H, Spiru L, Stomrud E, Struyfs H, Teunissen CE, Vos SJB, van Waalwijk van Doorn LJC, Waldemar G, Wallin ÅK, Wiltfang J, Zetterberg H. Association of Cerebral Amyloid-β Aggregation With Cognitive Functioning in Persons Without Dementia. JAMA Psychiatry. 2018 Jan 1;75(1):84-95. doi: 10.1001/jamapsychiatry.2017.3391. Erratum in: JAMA Psychiatry. 2018 Mar 1;75(3):303.
Ossenkoppele R, Jansen WJ, Rabinovici GD, Knol DL, van der Flier WM, van Berckel BN, Scheltens P, Visser PJ; Amyloid PET Study Group, Verfaillie SC, Zwan MD, Adriaanse SM, Lammertsma AA, Barkhof F, Jagust WJ, Miller BL, Rosen HJ, Landau SM, Villemagne VL, Rowe CC, Lee DY, Na DL, Seo SW, Sarazin M, Roe CM, Sabri O, Barthel H, Koglin N, Hodges J, Leyton CE, Vandenberghe R, van Laere K, Drzezga A, Forster S, Grimmer T, Sánchez-Juan P, Carril JM, Mok V, Camus V, Klunk WE, Cohen AD, Meyer PT, Hellwig S, Newberg A, Frederiksen KS, Fleisher AS, Mintun MA, Wolk DA, Nordberg A, Rinne JO, Chételat G, Lleo A, Blesa R, Fortea J, Madsen K, Rodrigue KM, Brooks DJ. Prevalence of amyloid PET positivity in dementia syndromes: a meta-analysis. JAMA. 2015 May 19;313(19):1939-49. doi: 10.1001/jama.2015.4669.
Skinner JS, Duke L, Wilkins CH. Why Ethnogeriatrics Is Important. Cummings-Vaughn L, Cruz-Oliver DM, eds. Ethnogeriatrics: Healthcare Needs of Diverse Populations. Cham: Springer International Publishing; 2017:3-17.

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Responsible Party: American College of Radiology
ClinicalTrials.gov Identifier: NCT04426539    
Other Study ID Numbers: New IDEAS
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
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
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.
URL: http://ideas-study.org
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders