New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

Launched by AMERICAN COLLEGE OF RADIOLOGY · Jun 9, 2020

Keywords

ClinConnect Summary

The New IDEAS study is looking at how a special type of brain scan, called an amyloid PET scan, can help understand Alzheimer's disease and other types of dementia. This study aims to see how the results from these scans relate to what matters most to patients, such as their daily living and quality of life. The study will involve a diverse group of Medicare beneficiaries aged 65 and older who show signs of mild cognitive impairment or dementia.

To participate, you need to be a Medicare beneficiary and have had a brain scan within the past two years. You should also be able to tolerate the amyloid PET scan and speak either English or Spanish. If you join the study, you'll have the PET scan done at a participating facility, and the information gathered will help researchers learn more about the impact of amyloid levels in the brain on cognitive health. It's important to know that this study is observational, meaning that it’s focused on collecting information rather than providing treatment.

Gender

ALL

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
• • 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).