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Brain scan study aims to improve dementia care for all

NCT ID NCT04426539

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

6,061 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Alzheimer disease Cognitive Dysfunction dementia

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.