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

NCT07646652 — Not yet recruiting, 40 participants, Stanford University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07646652
Status	Not yet recruiting
Study type	Observational
Enrollment	40 (Estimated)
Sponsor	Stanford University (Other)
Conditions	Lewy Body Disease
Interventions	LBD Biomarker Education and Disclosure (Other)
Dates	start 2026-11-01 (estimated), primary completion 2030-11-01 (estimated), completion 2030-11-01 (estimated), first posted 2026-06-15, last updated 2026-06-15
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Symptomatic Lewy body disease (LBD)		Other: LBD Biomarker Education and Disclosure	Participants undergo testing for alpha-synuclein, participate in a disclosure visit for their alpha-synuclein status, and fill out questionnaires before and after disclosure to assess their reaction to this information.
Asymptomatic (participants without symptoms of LBD or MSA)		Other: LBD Biomarker Education and Disclosure	Participants underwent testing for alpha-synuclein. They will participate in a disclosure visit for their alpha-synuclein status and fill out questionnaires before and after disclosure to assess their reaction to this information.

LBD Biomarker Education and Disclosure (Other): In-depth interviews as well as questionnaires will be conducted with individuals who have preclinical (early stage) or symptomatic LBD.

+Outcome measures

Primary outcomes

Change in distress scale score as measured by the Impact of Event Scale-Revised [Baseline, 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.

+Eligibility

Sex: All, ages: 40 Years to 85 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Stanford University	Stanford, California	United States

+Investigators

Irina A Skylar-Scott, MD, Principal investigator, Stanford University