Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study: A Study to Improve Precision in Amyloid PET Coverage and Patient Care

Translate

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04426539

Background Information

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.

Offered At

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

Eligibility Information

  • 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

Ineligibility Information

  • 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