NCT07646652Not yet recruiting
Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2030
- Lead sponsor
- Stanford University
- Diseases
- Lewy body dementia
- NCT number
- NCT07646652
What you commit to
- Study type: Observational
- Planned participants: 40
- From Nov 2026 to the primary completion date, Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- All Participants
- Clinician judgment that disclosure poses unacceptable psychological risk.
- Absence of a caregiver who can complete assessments.
Who the study is looking for
- 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).
Age in the registry: 40 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.