Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients

NCT04291066 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1445221
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Somatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission (Day 0), post injury (Day 7), and post injury (Day 30). The scale goes based on a 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, 4 = a severe problem. The RPQ scores can range between 0 and 64 where higher scores indicate more severe symptoms.

  0 to 30 days post traumatic brain injury event

Secondary Outcomes (1)

• Glasgow Coma Scale (GCS) at Arrival and Discharge

  Day 0 Score on arrival through subject discharge post traumatic brain injury event at approximately 30 days

Study Arms (2)

Treatment

EXPERIMENTAL

oral N-acetyl cysteine and oral multivitamin tablets

Drug: N-Acetyl cysteine

Non-Treatment

NO INTERVENTION

Routine Care

Interventions

N-Acetyl cysteine DRUG

Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI

Also known as: Multi-vitamins with minerals

Treatment

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• present to emergency department within 3 hours of documented TBI

You may not qualify if:

• 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.

Sponsors & Collaborators

• HonorHealth Research Institute: lead

Study Sites (2)

HonorHealth John C. Lincoln Medical Center

Phoenix, Arizona, 85020, United States

Location

HonorHealth Deer Valley Medical Center

Phoenix, Arizona, 85027, United States

Location

Related Publications (1)

• Mcpherson RA, Mangram AJ, Barletta JF, Dzandu JK. N -acetylcysteine is associated with reduction of postconcussive symptoms in elderly patients: A pilot study. J Trauma Acute Care Surg. 2022 Nov 1;93(5):644-649. doi: 10.1097/TA.0000000000003639. Epub 2022 Apr 8.

  PMID: 35393384 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Acetylcysteine; Minerals

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Inorganic Chemicals

Results Point of Contact

• Title: James K. Dzandu, PhD/Trauma Research Manager
• Organization: HonorHealth

jdzand@honorhealth.com

602-786-1023

Study Officials

• Ryab mcPherson, DO

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: March 2, 2020
• Study Start: September 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: August 1, 2021
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)