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

NCT07646652 | Not Yet Recruiting

• 1 other identifier: 87329
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lewy Body Disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Day 14, Day 30, Day 182

Study Arms (2)

Symptomatic Lewy body disease (LBD)

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.

Other: LBD Biomarker Education and Disclosure

Asymptomatic (participants without symptoms of LBD or MSA)

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.

Other: LBD Biomarker Education and Disclosure

Interventions

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.

Asymptomatic (participants without symptoms of LBD or MSA); Symptomatic Lewy body disease (LBD)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• \) 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Irina A Skylar-Scott, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Adult Neurology

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)