protocolSection identificationModule nctId: NCT06282965, orgStudyIdInfo id: AngT-001, briefTitle: Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury, acronym: ANGel T, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Arizona, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).The main questions this trial aims to answer are:* Is Angiotensin (1-7) safe?* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?Participants will:* Complete 21 days of study treatment consisting of a once-daily injection.* Provide blood samples.* Undergo two magnetic resonance imaging (MRI) scans of the brain.* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Investigators, study site staff, participants, and caregivers will be unaware of the participant treatment assignments for the duration of the study. The pharmacist will prepare the study treatment and will be unmasked., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Angiotensin (1-7), interventions name: Sterile saline, outcomesModule primaryOutcomes measure: Number of participants with adverse events, primaryOutcomes measure: Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog), secondaryOutcomes measure: Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), secondaryOutcomes measure: Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau), secondaryOutcomes measure: Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days, secondaryOutcomes measure: Effects of Angiotensin (1-7) on brain white matter integrity, secondaryOutcomes measure: Effects of Angiotensin (1-7) on length of hospital stay, secondaryOutcomes measure: Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM), secondaryOutcomes measure: Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False