New IDEAS Study Patient Eligibility Criteria

Inclusion Criteria

  1. Medicare beneficiary with Medicare as primary insurance;
  2. 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);
  3. Brain MRI and/or CT within 24 months prior to enrollment; 
  4. Clinical laboratory assessment (complete blood count [CBC], comprehensive metabolic panel[CMP], thyroid stimulating hormone [TSH], vitamin B12) within the 12 months prior to enrollment;
  5. Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
  6. Willing and able to provide consent. Consent may be by proxy;
  7. 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

  1. Normal cognition or subjective complaints that are not verified by cognitive testing or key informant.
  2. 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.
  3. Amyloid or tau status already known to patient or referring clinician based on prior imaging or cerebrospinal fluid analysis.
  4. Previous amyloid PET scan obtained. 
  5. Current or previous enrollment with an anti-amyloid agent. 
  6. Current or previous enrollment in an anti-amyloid therapeutic trial. 
  7. 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. 
  8. Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening). 
  9. Cancer requiring active therapy (excluding non-melanoma skin cancer). 
  10. Hip/pelvic fracture within the 12 months prior to enrollment. 
  11. Body weight exceeds PET scanner weight limit. 
  12. Currently pregnant or planning to become pregnant within 90 days of registration. 
  13. Life expectancy less than 24 months based on medical co-morbidities. 
  14. Residence in a skilled nursing facility (Note: assisted living facility is not an exclusion criterion).