Phase 2
Completed N=92
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Source: ClinicalTrials.gov NCT04291066 ↗Enrolled (actual)
92
Serious AEs
9.8%
Results posted
May 2026
Primary outcomePrimary: Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group. — 6; 11; 2; 10 score on a scale
Summary
This study will evaluate the administration of N-Acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (>60 years of age) who have experienced a traumatic brain injury.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group. |
6; 11; 2; 10; 0; 4 | — |
| SECONDARY Glasgow Coma Scale (GCS) at Arrival and Discharge |
15; 14.9; 15; 15 | — |
Eligibility Criteria
Inclusion Criteria
- 60 years or older
- present to emergency department within 3 hours of documented TBI
Exclusion Criteria
- patients without TBI
- patients with a history of TBI greater than 3 hours prior to presentation
- patients under the age of 60
- currently enrolled in an ongoing research study
- patients who at baseline prior to the TBI, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to TBI)
- Patients who are unable to tolerate PO medications within 3 hours of sustaining TBI.
Data sourced from ClinicalTrials.gov (NCT04291066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.