Evaluating the impact of amyloid PET imaging on dementia outcomes
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
This study is testing if using amyloid PET imaging can help improve care and outcomes for people with cognitive impairment, including those from different backgrounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American College of Radiology Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04426539 on ClinicalTrials.gov |
What this trial studies
New IDEAS is an observational study that aims to assess the relationship between amyloid PET imaging and patient-centered outcomes in a diverse group of Medicare beneficiaries with cognitive impairment. The study will enroll 7,000 participants over 30 months, ensuring representation from various racial and ethnic backgrounds. Participants will be classified based on their clinical presentation and disease stage prior to the PET scan. Dementia specialists will collaborate with trained radiologists to interpret the PET results and guide management decisions.
Who should consider this trial
Good fit: Ideal candidates include Medicare beneficiaries diagnosed with Mild Cognitive Impairment or Dementia who meet specific clinical criteria.
Not a fit: Patients with normal cognition or those who are not verified to have cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how amyloid PET imaging influences treatment decisions and outcomes for patients with cognitive impairment.
How similar studies have performed: Previous studies on amyloid PET imaging have shown promising results in understanding Alzheimer's disease, indicating that this approach is building on established research.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Philadelphia, Pennsylvania
- Full list of Active Sites and Imaging Facilities — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: New IDEAS Study Team
- Email: ideas-study@acr.org
- Phone: 215-574-3229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.