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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Full list of Active Sites and Imaging Facilities
RECRUITING
Philadelphia
Contact Information
Primary
New IDEAS Study Team
ideas-study@acr.org
215-574-3229
Time Frame
Start Date: 2020-12-17
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 7000
Treatments
Amyloid PET-Positive
Those for whom a beta amyloid PET scan is consistent with underlying AD as causing or contributing to cognitive impairment
Amyloid PET-Negative
Those for whom a beta amyloid PET scan has ruled out AD (i.e. not consistent with underlying AD as causing or contributing to cognitive impairment)
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: American College of Radiology

This content was sourced from clinicaltrials.gov