Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

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

This is a pilot/feasibility study of memantine in severe traumatic brain injury (TBI) persons, employing a randomized, double-blind, placebo-controlled, design. Outcome evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.

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