protocolSection identificationModule nctId: NCT06297590, orgStudyIdInfo id: 18795, secondaryIdInfos id: J4T-MC-OLAA, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2024-510604-37-00, type: OTHER, domain: EU Trial Number, secondaryIdInfos id: U1111-1302-6222, type: OTHER, domain: Universal Trial Number, briefTitle: A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A.If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: LY3954068, interventions name: Placebo, interventions name: Flortaucipir F18, outcomesModule primaryOutcomes measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, primaryOutcomes measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, secondaryOutcomes measure: Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Optional Part B: PK: Cmax, secondaryOutcomes measure: Part A: PK: Area Under the Concentration Versus Time Curve (AUC), secondaryOutcomes measure: Optional Part B: PK: AUC, secondaryOutcomes measure: Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068, secondaryOutcomes measure: Optional Part B: PK: CSF concentration of LY3954068, secondaryOutcomes measure: Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau, secondaryOutcomes measure: Optional Part B: PD: Change from Baseline of CSF tau, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: K2 Medical Research LLC, city: Maitland, state: Florida, zip: 32751, country: United States, contacts role: CONTACT, phone: 407-500-5252, contacts name: Brandon Lenox, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Charter Research, LLC, city: The Villages, state: Florida, zip: 32162, country: United States, contacts role: CONTACT, phone: 352-775-1000, contacts name: Jeffrey Norton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.93408, lon: -81.95994, locations facility: Indiana University School of Medicine - Clinical Research Center, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts role: CONTACT, phone: 317-963-7505, contacts name: Jared Brosch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Massachusetts General Hospital (MGH), city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts role: CONTACT, phone: 617-643-5607, contacts name: Steven Arnold, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.37787, lon: -71.062, locations facility: CenExel AMRI, city: Toms River, state: New Jersey, zip: 08755, country: United States, contacts role: CONTACT, phone: 732-341-9500, contacts name: Sanjiv Sharma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95373, lon: -74.19792, locations facility: Duke University, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Shruti Raja, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts role: CONTACT, phone: 414-955-0650, contacts name: Malgorzata Franczak, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.0389, lon: -87.90647, locations facility: The University of Tokyo Hospital, city: Bunkyo-ku, state: Tokyo, zip: 113-8655, country: Japan, contacts role: CONTACT, phone: +81-33-815-5411, contacts name: Takeshi Iwatsubo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.37517, lon: 139.92991, locations facility: National Hospital for Neurology and Neurosurgery (UCLH), city: London, zip: WC1N 3BG, country: United Kingdom, contacts role: CONTACT, phone: 0203 448 3011, contacts name: Catherine Mummery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Hallamshire Hospital, city: Sheffield, zip: S10 2JF, country: United Kingdom, contacts name: Daniel Blackburn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, locations facility: University Hospital Southampton, city: Southampton, zip: SO16 6YD, country: United Kingdom, contacts name: Christopher Kipps, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False