Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LBD Biomarker Education and Disclosure.
- Who it may be relevant to
- Registry conditions: Lewy Body Disease. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other LBD Biomarker Education and Disclosure
In-depth interviews as well as questionnaires will be conducted with individuals who have preclinical (early stage) or symptomatic LBD.
Primary outcome measures
- Change in distress scale score as measured by the Impact of Event Scale-Revised [Time frame: Baseline, Day 14, Day 30, Day 182]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT07646652 · 87329