Brain scan study aims to improve dementia care for all
NCT ID NCT04426539
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This completed study followed over 6,000 Medicare patients with memory problems to see if a special brain scan (amyloid PET) helps doctors make better care decisions. The study included a diverse group of participants to ensure findings apply to everyone. It did not test a new drug or treatment, but rather looked at how the scan results relate to patient outcomes over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could show how amyloid PET scans help doctors manage dementia more effectively, especially in diverse groups.
- What could go wrong
- This is an observational study, not a treatment trial. It cannot prove that PET scans improve outcomes, only that they are associated with certain care patterns.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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6,061 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will be consented and enrolled over 30 months at sites throughout the United States. To ensure diversity, the study will enroll at least 2,000 Blacks/African Americans, at least 2,000 Latinos/Hispanics, and up to 3,000 additional participants from other racial and ethnic backgrounds. Based on disease stage prior to PET, all participants will be classified as having MCI or dementia as their disease stage. Based on their clinical presentation prior to PET, all participants will be classified as having "typical" (i.e. progressive amnestic) or "atypical" clinical presentations of AD as the potential cause of dementia or MCI.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Full list of Active Sites and Imaging Facilities
Philadelphia, Pennsylvania, 19103, United States
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