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New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

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Brief Summary

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.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
  • 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

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 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).

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Study Stats
Protocol No.
21-000577
Category
Brain/Neurological Diseases
Contact
Nancy Osuch
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04426539
For detailed technical eligibility, visit ClinicalTrials.gov.