NCT07646652
Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease
Not Yet Recruiting
Not specifiedAges 40–85ObservationalStanford UniversityInvestigator-initiated
~40 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:LBD Biomarker Education and Disclosure
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in distress scale score as measured by the Impact of Event Scale-Revised
Measured over Baseline, Day 14, Day 30, Day 182
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Irina A Skylar-Scott, MD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
Olivia Lu
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
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)
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
Clinician judgment that disclosure poses unacceptable psychological risk.
Concurrent enrollment in a trial with conflicting disclosure protocols.
What this trial measures
- Change in distress scale score as measured by the Impact of Event Scale-RevisedBaseline, Day 14, Day 30, Day 182
Distress related to biomarker disclosure will be assessed via the validated Impact of Event Scale-Revised (IES-R, a 22 item self-report measure). Scores range from 0 to 88; higher scores mean greater distress.