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Study to reveal emotional impact of lewy body biomarker disclosure

NCT ID NCT07646652

Knowledge-focused Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study from Stanford University will look at how people react when they learn their Lewy Body Disease biomarker test results. Researchers will interview and survey 40 participants, both with and without symptoms, to measure distress and other responses over time. The goal is to understand the best ways to share this sensitive information.

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 could help doctors understand how to best share biomarker results with patients, improving care and support.
What could go wrong
This is a small, early-stage study with only 40 participants, so findings may not apply to everyone. It focuses on education, not treatment.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

An estimate. End dates often move.

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

Participants who have preclinical (early stage) or symptomatic Lewy Bodies Dementia.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 All Participants * Able to provide 1) written, informed consent or 2) assent if a care partner can provide consent. * Access to a primary care or neurology provider for ongoing care. * 1\) willing to undergo skin biopsy or lumbar puncture for alpha-synuclein testing or 2) has access to as-yet undisclosed skin biopsy or lumbar puncture alpha-synuclein testing results. Healthy/Asymptomatic Arm * Undergoing testing for defined reason (e.g., research study) * Mini-Mental State Examination score between 26 and 30 (or MoCA between 25 and 30) * General good health (no diseases expected to interfere with the study) Symptomatic Arm \[Concern for dementia with Lewy bodies (DLB), Parkinson's disease (PD), or multiple system atrophy (MSA)\] * Referred by a neurologist or movement disorder specialist * Adults with any of the following: symptomatic LBD, mild cognitive impairment with Lewy body (MCI-LB), Parkinson's disease dementia (PDD), MCI in Parkinson's disease (PD-MCI), or criteria for multiple system atrophy (MSA). Exclusion criteria: All Participants * Clinician judgment that disclosure poses unacceptable psychological risk. * Concurrent enrollment in a trial with conflicting disclosure protocols. Healthy/Asymptomatic Arm • Neurological diagnosis at the time of biomarker assessment (e.g., Alzheimer's disease, Parkinson's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, etc.) Symptomatic Arm • Absence of a caregiver who can complete assessments.

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Conditions

The condition(s) this trial relates to.

Lewy body dementia Lewy Body Disease multiple system atrophy

As listed by the trial registrant

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

Lewy body disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

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