Status:
RECRUITING
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
Lead Sponsor:
American College of Radiology
Collaborating Sponsors:
Alzheimer's Association
Conditions:
Alzheimer's Disease
Dementia
Eligibility:
All Genders
18+ years
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...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
7000 Patients enrolled
Trial Details
Trial ID
NCT04426539
Start Date
December 17 2020
End Date
December 31 2024
Last Update
May 16 2024
Active Locations (1)
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1
Full list of Active Sites and Imaging Facilities
Philadelphia, Pennsylvania, United States, 19103