Lewy Body DiseaseNCT07646652
Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease
An observational study of Lewy Body Disease, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lewy Body Disease
- What is being tested?
- LBD Biomarker Education and Disclosure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who have preclinical (early stage) or symptomatic Lewy Bodies Dementia.
Who may be able to join
- 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)
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Stanford, California, 94305
Olivia Lu, olivialu@stanford.edu
Hannah Lawrence, hannah8@stanford.edu
About this study
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
- Being tested
- LBD Biomarker Education and Disclosure
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBD Biomarker Education and DisclosureOther
In-depth interviews as well as questionnaires will be conducted with individuals who have preclinical (early stage) or symptomatic LBD.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: LBD Biomarker Education and Disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 14, Day 30, Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Anna Skylar-Scott, Stanford University
- Investigators
- Irina A Skylar-Scott, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646652
- Sponsor's protocol ID
- 87329
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease
- ClinicalTrials.gov ID
- NCT07646652
- Acronym / sponsor ID
- 87329
- Conditions
- Lewy Body Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Lewy body disease (LBD) | – | Other: LBD Biomarker Education and DisclosureParticipants 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) | – | Other: LBD Biomarker Education and DisclosureParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have preclinical (early stage) or symptomatic Lewy Bodies Dementia.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBD Biomarker Education and DisclosureIn-depth interviews as well as questionnaires will be conducted with individuals who have preclinical (early stage) or symptomatic LBD. | Other | Asymptomatic (participants without symptoms of LBD or MSA), Symptomatic Lewy body disease (LBD) |
Primary outcome
Change in distress scale score as measured by the Impact of Event Scale-Revised
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Lewy Body Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irina A Skylar-Scott, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lewy Body Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distress scale score as measured by the Impact of Event Scale-Revised (time frame: Baseline, Day 14, Day 30, Day 182). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.