Dementia Clinical Trial
Official title:
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
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.
Status | Recruiting |
Enrollment | 7000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Full list of Active Sites and Imaging Facilities | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
American College of Radiology | Alzheimer's Association |
United States,
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* Note: There are 71 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 12 Months | |
Primary | 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. | 12 Months | |
Secondary | 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. | 12 Months |
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