protocolSection identificationModule nctId: NCT06274528, orgStudyIdInfo id: 202301150, briefTitle: DORA and LP in Alzheimer's Disease Biomarkers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2029-03-11, completionDateStruct date: 2029-03-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the fluid around the brain known as cerebrospinal fluid (CSF). Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Pharmacist, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 201, type: ESTIMATED, armsInterventionsModule interventions name: Lemborexant 10 mg, interventions name: Lemborexant 20mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes CSF pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo, secondaryOutcomes measure: Number of participants with treatment-related adverse events, secondaryOutcomes measure: Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181, secondaryOutcomes measure: Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42), secondaryOutcomes measure: Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42), secondaryOutcomes measure: Measure changes of blood plasma p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217)., secondaryOutcomes measure: Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217)., otherOutcomes measure: Measure changes of cerebrospinal TREM2 (exploratory), otherOutcomes measure: Measure changes of cerebrospinal NPTX2 (exploratory), otherOutcomes measure: Measure changes of cerebrospinal NfL (exploratory), otherOutcomes measure: Measure changes of blood plasma NfL (exploratory), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University in St. Louis, School of Medicine, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Cristina Toedebusch, BS, role: CONTACT, phone: 314-747-0646, email: toedebuschc@wustl.edu, contacts name: Chloe Meehan, BS, MA, role: CONTACT, phone: 314-273-0878, email: cmeehan@wustl.edu, contacts name: Brendan P. Lucey, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: J. Philip Miller, Ph.D., role: SUB_INVESTIGATOR, contacts name: Jason Hassenstab, Ph.D., role: SUB_INVESTIGATOR, contacts name: David Carr, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False