Status:
COMPLETED
Effects of Keppra on Thinking, Emotions, and Balance in Elderly Healthy Volunteers
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Michael Schoenberg, Ignacio Pita, Kyra Dawson
Conditions:
Epilepsy
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief Summary
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. Unfo...
Detailed Description
III. INTRODUCTION: Background Antiepileptic Drugs And Cognitive Dysfunction Epilepsy is the most common debilitating neurologic disorder, with a prevalence of about 6/1000 in the general population (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Exclusion Criteria
- 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.
- \-
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00221988
Start Date
March 1 2004
End Date
October 1 2007
Last Update
May 18 2022
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106