Lewy Body Disease
Conditions
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.
Interventions
OTHERLBD Biomarker Education and Disclosure
In-depth interviews as well as questionnaires will be conducted with individuals who have preclinical (early stage) or symptomatic LBD.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIrina A Skylar-Scott, MD
Stanford University
Outcome results
None listed