Phase
Condition
Neurologic Disorders
Traumatic Brain Injury
Memory Loss
Treatment
N/AClinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients will have persistent memory and attention deficits due to a closed traumaticbrain injury not less than one year prior to entrance in the study.
Meet or exceed American Congress of Rehabilitation Medicine (ACRM) criteria for mildTBI.
Mini-Mental State Exam (MMSE) score of 20 to 27 at the screening visit or a CaliforniaVerbal Learning Test (CVLT) score for trials 1-5 one standard deviation lower than theage matched normative score. The CVLT score from the medical record may be used forentry criteria if it was obtained one year or more post-TBI and within two years ofstudy entry.
Galveston Orientation and Amnesia Test (GOAT) score of at least 75.
Be of sufficient cognitive ability to complete neuropsychological tests.
Male or female, 18-50 years of age.
Females of childbearing potential must use acceptable means of birth control and havea negative screening beta-human chorionic gonadotrophin (b-HCG) pregnancy test.Acceptable birth control includes hormonal birth control (such as oral birth controlpills, implanted or injected contraceptives), an intrauterine device (IUD), surgicalsterilization (such as tubal ligation or hysterectomy), a spermicide with barriermethods (condoms or diaphragm), or a partner who has had a vasectomy.
Patients taking donepezil (Aricept) or rivastigmine (Exelon) must be at a steady statedose for a minimum of six months.
Patients taking any other medication(s) affecting cognition must be at a steady statedose for a minimum of two months.
Able to provide written informed consent.
Able to read, write, and speak in English.
Willing and able to comply with the physician's instructions for all aspects of thestudy.
Exclusion
Exclusion Criteria:
Patients must not have any medical or psychiatric disorder that in the opinion of thePI would interfere with or bias the assessment of efficacy or place their health atrisk when placed on the memantine (Namenda) regimen.
Patients with a history of seizure are excluded.
Patients with a history of severe renal insufficiency are excluded.
Patients must not have taken any experimental drug within the last 30 days prior toentering the protocol.
Patients must not have taken any drug known to have major organ system toxicity withinthe last 30 days prior to entering the protocol.
Women who are pregnant, nursing, or intend to become pregnant during the study areexcluded.
Patients with a penetrating TBI are excluded.
Patients whose screening laboratory values are 1.5 times greater than upper limits ofnormal range(ULN) are excluded.
Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg ordiastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg at the screeningvisit are excluded.
Concomitant use of amantadine (Symmetrel) is prohibited and a washout period of 4weeks is required before study entry.
Study Design
Study Description
Connect with a study center
University of Missouri-Columbia
Columbia,, Missouri 65212
United StatesSite Not Available
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