Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Memantine; Placebo
Intervention description: After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study.; After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: traumatic brain injury; memory; attention

Summary:

      The purpose of this study is to determine whether memantine (Namenda) improves memory and
      attention in patients with mild to moderate traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients will have persistent memory and attention deficits due to a closed traumatic
             brain injury not less than one year prior to entrance in the study.

          2. Meet or exceed American Congress of Rehabilitation Medicine (ACRM) criteria for mild
             TBI.

          3. Mini-Mental State Exam (MMSE) score of 20 to 27 at the screening visit or a California
             Verbal Learning Test (CVLT) score for trials 1-5 one standard deviation lower than the
             age matched normative score. The CVLT score from the medical record may be used for
             entry criteria if it was obtained one year or more post-TBI and within two years of
             study entry.

          4. Galveston Orientation and Amnesia Test (GOAT) score of at least 75.

          5. Be of sufficient cognitive ability to complete neuropsychological tests.

          6. Male or female, 18-50 years of age.

          7. Females of childbearing potential must use acceptable means of birth control and have
             a negative screening beta-human chorionic gonadotrophin (b-HCG) pregnancy test.
             Acceptable birth control includes hormonal birth control (such as oral birth control
             pills, implanted or injected contraceptives), an intrauterine device (IUD), surgical
             sterilization (such as tubal ligation or hysterectomy), a spermicide with barrier
             methods (condoms or diaphragm), or a partner who has had a vasectomy.

          8. Patients taking donepezil (Aricept) or rivastigmine (Exelon) must be at a steady state
             dose for a minimum of six months.

          9. Patients taking any other medication(s) affecting cognition must be at a steady state
             dose for a minimum of two months.

         10. Able to provide written informed consent.

         11. Able to read, write, and speak in English.

         12. Willing and able to comply with the physician's instructions for all aspects of the
             study.

        Exclusion Criteria:

          1. Patients must not have any medical or psychiatric disorder that in the opinion of the
             PI would interfere with or bias the assessment of efficacy or place their health at
             risk when placed on the memantine (Namenda) regimen.

          2. Patients with a history of seizure are excluded.

          3. Patients with a history of severe renal insufficiency are excluded.

          4. Patients must not have taken any experimental drug within the last 30 days prior to
             entering the protocol.

          5. Patients must not have taken any drug known to have major organ system toxicity within
             the last 30 days prior to entering the protocol.

          6. Women who are pregnant, nursing, or intend to become pregnant during the study are
             excluded.

          7. Patients with a penetrating TBI are excluded.

          8. Patients whose screening laboratory values are 1.5 times greater than upper limits of
             normal range(ULN) are excluded.

          9. Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg or
             diastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg at the screening
             visit are excluded.

         10. Concomitant use of amantadine (Symmetrel) is prohibited and a washout period of 4
             weeks is required before study entry.