Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria
All Participants
Healthy/Asymptomatic Arm
Symptomatic Arm [Concern for dementia with Lewy bodies (DLB), Parkinson's disease (PD), or multiple system atrophy (MSA)]
Exclusion criteria:
All Participants
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.
Not provided
Not provided
Participants who have preclinical (early stage) or symptomatic Lewy Bodies Dementia.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Irina A Skylar-Scott, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |