New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study (NCT04426539) | Clinical Trial Compass
CompletedNot Applicable
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
United States6,061 participantsStarted 2020-12-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 autoso…
What they're measuring
1
Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative