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 (Refer to full study protocol section 4.1.1. for more guidance);
- Brain MRI and/or CT within 24 months prior to enrollment;
- Clinical laboratory assessment (complete blood count [CBC], comprehensive metabolic panel[CMP], 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;
- 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 full study protocol section 4.1.2. for additional 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 or tau status already known to patient or referring clinician based on prior imaging or cerebrospinal fluid analysis.
- Previous amyloid PET scan obtained.
- Current or previous enrollment with an anti-amyloid agent.
- 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 (Note: assisted living facility is not an exclusion criterion).