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.

Inova Medical Group – Neurology
8081 Innovation park Dr., #900
Fairfax, VA 22031

• Adults ≥ 18 years of age
• 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

• 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)

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04426539?term=NCT04426539&draw=2&rank=1