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.
Participant or representative willing to provide informed consent.
Age 18 years or older at time of enrollment.
Traumatically induced head injury resulting from insult to head from an external force.
Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available.
Time of injury cannot be determined.
Neurosurgery within the last 30 days.
History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.
Contraindication to having an MRI.
University of Arizona
Lead sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator