Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury - Trial NCT06282965
Access comprehensive clinical trial information for NCT06282965 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by University of Arizona and is currently Not yet recruiting. The study focuses on Traumatic Brain Injury. Target enrollment is 90 participants.
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Study Focus
Sponsor & Location
University of Arizona
Timeline & Enrollment
Phase 1/2
Mar 01, 2024
Sep 01, 2027
Primary Outcome
Number of participants with adverse events,Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06282965
Non-Device Trial