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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
The drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight.
Sterile solution of 0.9% NaCl in water.
University of Arizona
Tucson, Arizona, United States
RECRUITINGNumber of participants with adverse events
The number of participants with adverse events in each group will be compared in order to determine whether Angiotensin (1-7) is significantly associated with the occurrence of adverse events.
Time frame: At 21 days
Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment consisting of eleven tasks. It is used to assess cognitive function. Errors in each task are summed for a total score ranging from 0 to 70. Higher scores represent greater cognitive dysfunction, with a score of 0 representing the least impairment and a score of 70 representing the greatest impairment.
Time frame: 90 days
Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA)
Difference in performance for the treatment groups compared to controls on the Montreal Cognitive Assessment (MoCA). The range of possible scores is 0-30, with scores of 26 and above being considered normal.
Time frame: 90 days
Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Differences between the treatment groups and controls on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), a 23-item inventory to assess daily functioning by asking about the participant's performance of multiple activities in the past four weeks. Scores range from 0 to 78, with 0 indicating the greatest disability.
Time frame: 90 days
Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau)
Change in phosphorylated tau (p-tau), a biomarker which can predict cognitive decline, cognitive impairment, and dementia.
Time frame: Enrollment to 21 days
Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days
Change in phosphorylated tau (p-tau), a biomarker which can predict cognitive decline, cognitive impairment, and dementia.
Time frame: Enrollment to 90 days
Effects of Angiotensin (1-7) on brain white matter integrity
Assessment of difference in white matter integrity calculated from MR images.
Time frame: MRI baseline to 90 days
Effects of Angiotensin (1-7) on length of hospital stay
Length of stay will be calculated as the difference between the admission and discharge dates.
Time frame: Admission to discharge, average of 5 days
Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM)
The Confusion Assessment Method (CAM) is used to diagnose delirium using an algorithm based on the following features: 1. Acute onset and fluctuating course. 2. Inattention. 3. Disorganized thinking. 4. Altered level of consciousness.
Time frame: Admission to discharge, average of 5 days
Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a brief questionnaire used to assess the severity of symptoms of depression. The range of possible scores is 0-27, with a higher score indicating greater depression severity.
Time frame: Enrollment to 21 days, enrollment to 90 days
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