[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07646652":3,"trial-entities:NCT07646652":83,"trial-summary:NCT07646652":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":40,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":56,"locations":59,"central_contacts":76,"overall_officials":77,"references":81,"see_also_links":82},"NCT07646652","87329","Alpha-synuclein Education and Disclosure in Individuals With Preclinical and Symptomatic Lewy Body Disease","NOT_YET_RECRUITING","2030-11","2026-06","2026-06-15","2026-11","Stanford University","OTHER",false,"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.",null,[18],"Lewy Body Disease",[],"OBSERVATIONAL",[],{"count":23,"type":24},40,"ESTIMATED",[26],{"type":13,"name":27,"description":28,"armGroupLabels":29},"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.",[30,31],"Asymptomatic (participants without symptoms of LBD or MSA)","Symptomatic Lewy body disease (LBD)",[33],{"measure":34,"description":35,"timeFrame":36},"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",[],"ALL","40 Years","85 Years",true,{"inclusion":43,"exclusion":52,"raw_text":55},[44,45,46,47,48,49,50,51],"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.","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)","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).",[53,54],"Clinician judgment that disclosure poses unacceptable psychological risk.","Concurrent enrollment in a trial with conflicting disclosure protocols.","Inclusion Criteria\n\nAll Participants\n\n* Able to provide 1) written, informed consent or 2) assent if a care partner can provide consent.\n* Access to a primary care or neurology provider for ongoing care.\n* 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.\n\nHealthy\u002FAsymptomatic Arm\n\n* Undergoing testing for defined reason (e.g., research study)\n* Mini-Mental State Examination score between 26 and 30 (or MoCA between 25 and 30)\n* General good health (no diseases expected to interfere with the study)\n\nSymptomatic Arm \\[Concern for dementia with Lewy bodies (DLB), Parkinson's disease (PD), or multiple system atrophy (MSA)\\]\n\n* Referred by a neurologist or movement disorder specialist\n* 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).\n\nExclusion criteria:\n\nAll Participants\n\n* Clinician judgment that disclosure poses unacceptable psychological risk.\n* Concurrent enrollment in a trial with conflicting disclosure protocols.\n\nHealthy\u002FAsymptomatic 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.)\n\nSymptomatic Arm\n\n• Absence of a caregiver who can complete assessments.",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":12,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"Stanford","California","94305","United States",[66,70],{"name":67,"role":68,"email":69},"Olivia Lu","CONTACT","olivialu@stanford.edu",{"name":71,"role":68,"email":72},"Hannah Lawrence","hannah8@stanford.edu",{"lat":74,"lon":75},37.42411,-122.16608,[],[78],{"name":79,"affiliation":12,"role":80},"Irina A Skylar-Scott, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":91},[85,86,87,88,89,90],"Dementia associated with Parkinson's Disease","Lewy Body Dementia","Mild cognitive disorder","Mild Cognitive Impairment in Parkinson's Disease","Multiple System Atrophy","Parkinson Disease",[92],"Alpha-Synuclein",{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]