New IDEAS Study Patient Eligibility Criteria

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:2 (Refer to protocol section 4.1.1 of the protocol for guidance);
  • 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. (Refer to protocol section 4.1.2 for guidance)

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 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;
  • 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).