Effects of Keppra on Thinking, Emotions, and Balance in Elderly Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00221988
Verified September 2005 by University Hospitals Cleveland Medical Center. Recruitment status was: Recruiting
Epilepsy is a common disorder with an incidence of about 6 per 1000. The incidence progressively increases above age 50. By age 75, the incidence is two to three fold compared with any age group. Unfortunately, older individuals are especially at risk to incur significant side effects to anti-epileptic drugs. A newer anti-epileptic drug may markedly improve seizure management in older individuals as it is removed by the kidneys and not the liver and does not interact with other medications. We expect it to be tolerated well in terms of effects on memory, thinking,balance, and walking. The current study assesses the side effects of levetiracetam in healthy volunteers aged 65 to 80. Use of healthy volunteers eliminates the effects of seizures on the outcome.
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Ages Eligible for Study:
65 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Study Population Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply. A subject must:
Provide a copy of their medical records from a primary care physician for the past year to assist in establishing the patient’s current health status. The study physician will review PCP medical records to assure participants meet the study inclusion/exclusion criteria.
Be a healthy adult age 65 to 80 years old. Healthy subjects are defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychiatric disease as determined by history and physical examination.
Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable.
Subjects must score within –1.0 standard deviations of the mean performance of healthy individuals on the neuropsychological tests at screen (week –2). Subjects must have a reading equivalency of 8th grade. Participants must also have a MMSE score of 28. (Bravo & Herbert, 1997; Crum et al., 1993). Finally, participants must score a 45 or better on the Berg Balance Test at screening (week –2) to be included in the study.
Sign an informed consent.
For participants living alone, provide the name and number of at least one friend or family member that study personnel may contact in the unlikely event that study personnel are unable to contact the patient by phone past 48 hours of a scheduled phone contact time which was not planned.
A subject will not be eligible for inclusion in this study if any of the following criteria apply. A subject must not:
Have a history of any type of epilepsy.
Be taking any concomitant medications that are or any concomitant medications that may alter cognitive function or mood.
Have a current or past history of drug or alcohol abuse or dependence. Have a positive urine toxicology test at screen.
Have a history and clinical finding of a progressive encephalopathy including CNS tumors of all types.
Have a serious illness in the past month that may confound the interpretation of study results.
Be on anticoagulation with warfarin.
Have experienced a prior adverse reaction or hypersensitivity to either study medication or to related compounds.
Be currently participating in another clinical study in which the subject will be exposed to an investigational or a non-investigational drug or device.