Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Memantine

Criteria

Inclusion Criteria:

• 18-65 years old of age at time of enrollment

• Severe traumatic brain injury (TBI)

• Feeding access (e.g., orogastric (OG), nasogastric (NG), or percutaneous endoscopic gastrostomy (PEG) tube) permitting delivery of memantine or placebo

• Availability of legally-authorized representative (LAR) to provide consent and participate in some study activities (e.g., monitoring for side effects, providing information about the patient)

Exclusion Criteria:

• Pre-existing history of serious neurological disorder

• Pre-existing history of serious psychiatric disorder (e.g., schizophrenia)

• Anticipated poor prognosis, based on the presence of bilaterally fixed and dilated pupils, severe hemodynamic instability, severe elevations in intracranial pressure refractory to interventions, or other factors leading to a determination of a probable non-survivable injury

• Primarily penetrating mechanism of injury (e.g., gunshot wound to the head)

• Isolated epidural hematoma with anticipated good prognosis

• Low probability of participant being compliant or being able to finish study procedures (e.g., present for outcome rating) in the judgment of the investigator

• Not English speaking (due to inability to complete outcome measure)

• Medical contraindications to memantine: Severe hepatic impairment (defined as albumin > 15gm/dL, Alk Phos > 375 U/L, ALT > 150 U/L, AST > 120 U/L or bilirubin > 3mg/dL). Moderate-to-Severe renal impairment (defined as creatinine clearance < 60)

• Pregnancy or breastfeeding