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New study aims to predict end of life in lewy body dementia

NCT ID NCT04829656

Knowledge-focused Sponsor: University of Florida Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This completed study followed 378 people with moderate-to-severe Lewy body dementia and their caregivers for up to three years. Researchers collected surveys and some physical exams to track symptoms, caregiver stress, and quality of life. The goal was to find clues that signal when a person is in their last six months of life, so families and doctors can better prepare and provide comfort.

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 help doctors and families better predict when someone with Lewy body dementia is nearing the end of life, leading to more compassionate and timely care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change the course of the disease. The findings may not apply to everyone with DLB, especially those outside the U.S.

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

378 people

The number who actually took part.

Started

Feb 2021

Finished

Dec 2025

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

Patients at five LBDA Research Centers of Excellence clinics may enroll into the study if they meet inclusion criteria. Clinics participating in the study are located at the University of Florida, Gainesville, FL; University of Miami, Miami, FL; University of Virginia, Charlottesville, VA; University of Michigan, Ann Arbor, MI; and the Mayo Clinic, Rochester, MN. People who have indicated interest in research opportunities through the LBDA mailing listserv will be emailed study information, including how to enroll.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patient and caregiver willing to participate as a dyad (patients will need a legally authorized representative to consent on their behalf given the requirement for at least moderate dementia, but patients who resists participating in the study will not be enrolled) * U.S. residents (i.e., individuals accessing the LBDA from outside the U.S. will be excluded) * Patient with a clinical diagnosis of DLB * Patient with moderate severity dementia as assessed by the Quick Dementia Rating System (QDRS, with a score of \>12 OR ≥2 in at least 3 domains suggestive of moderate dementia) * Caregiver telephone interview for cognitive status (TICS) score of \>31 to ensure that the caregiver is able to reliably complete study visits * Patient participant expected to live at least 6 months (so that at least a baseline visit and 1 follow up visits is expected to be completed) Exclusion Criteria: * Patient participant diagnosed with dementia of less than moderate severity * Patient with dementia resists participation * Non-U.S. residents * Patient participant with dementia not expected to live at least 6 months * Virtual cohort ONLY: Patient participant receives medical care from a LBDA Research Centers of Excellence clinic

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Conditions

The condition(s) this trial relates to.

dementia Lewy body dementia Lewy Body Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia with lewy bodies

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48105, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

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