NCT04426539Completed
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6061 (actual)
- First submitted
- 8 Jun 2020
- Start date
- 17 Dec 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- American College of Radiology
- Diseases
- Alzheimer disease
- NCT number
- NCT04426539
What you commit to
- Study type: Observational
- Participants enrolled: 6061
- From 17 Dec 2020 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Hip/pelvic fracture within the 12 months prior to enrollment.
Other illness
- 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.
- 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.
- Cancer requiring active therapy (excluding non-melanoma skin cancer).
Other
- Normal cognition or subjective complaints that are not verified by cognitive testing or key informant.
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
- 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).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Full list of Active Sites and Imaging Facilities Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.