Not Yet RecruitingNot Applicable

Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease

United States40 participantsStarted 2026-11

Plain-language summary

The goal of the study is to assess if learning one's Lewy Body Dementia (LBD) biomarker test result impacts longitudinal psychosocial and behavioral responses and to identify factors that moderate and mediate these outcomes.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.) Sympto…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in distress scale score as measured by the Impact of Event Scale-Revised

Timeframe: Baseline, Day 14, Day 30, Day 182

Trial details

NCT IDNCT07646652

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-11

View on ClinicalTrials.gov More Lewy Body Disease trials

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.