New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
Completed
Conditions studied: Alzheimer's Disease, Dementia, Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT04426539
- Run by
- American College of Radiology
- People needed
- 6061
- Starts
- 2020-12-17
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Full list of Active Sites and Imaging Facilities — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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