Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      Elderly persons with dementia are at risk for seizures, however, traditional anticonvulsants
      are poorly tolerated in this population. Our goal is to examine Levetiracetam (Keppra) in
      elderly dementia patients with seizures. While it has been established that Keppra controls
      seizures in this age group, it is important to demonstrate that treatment with Keppra would
      not affect cognitive abilities in this large population of patients . As this population is
      already cognitively impaired, the best choice of anticonvulsant would be one that does not
      further compromise their cognitive abilities. Keppra is an excellent anticonvulsant agent in
      the elderly for a variety of reasons, including safety, favorable side effect profile, lack
      of interaction with other drugs, and efficacy. Our retrospective pilot data suggests that
      cognition is not negatively affected by Keppra. The current prospective study will assess the
      cognitive abilities of persons with cognitive impairment at baseline and at weeks 4 and 12.
      The overall objective is to determine the cognitive tolerability of Keppra for seizures in
      elderly cognitively impaired patients.
    

Detailed description: 
      This is a prospective, phase 4, open label, twelve week study. The study will consist of a 4
      week titration phase followed by an 8 week assessment phase. All clinic visits will be
      conducted at Drexel University College of Medicine Department of Neurology at 219 N. Broad
      St., Phila., PA.

      Visit one will include reviewing and signing the written informed consent form, obtaining
      relevant demographic data, and then routine blood work. The baseline frequency, duration and
      type of seizures our subjects experience will be documented, as will their current
      antiepileptic medications. Baseline history and a physical and neurological examination will
      be performed, including vital signs. Testing will include baseline measurements of cognition,
      function (activities of daily living), and behavior. Cognitive testing will include
      Folstein's Minimental State examination (MMSE), and the ADAS-cog. Our overall assessment will
      include the Modified Schwab and England Activities of Daily Living Scale. Behavioral
      assessment will include Tariot's Behavior Ratings Scale and the Cohen-Mansfield Agitation
      Inventory (CMAI; long form). Levetiracetam will be initiated and instructions for follow up
      will be given. Because the goal is cognitive tolerability, Levetiracetam will be used as
      either an add-on agent or as primary monotherapy.

      During week two, a follow up telephone assessment will be done to review the instructions and
      to determine whether any medical changes or adverse events occurred. Adverse events will be
      assessed by direct questioning and spontaneous patient/caregiver reports. The date, number,
      duration and type of seizures any of our subjects experience will also be documented.

      At the third assessment (week 4), a follow up physical and neurological examination will be
      done, including vital signs, and the mental testing, including the tests of cognition,
      function and behavior will be repeated. An assessment will be made to determine whether
      adverse events occurred. Adverse events will be assessed by review of the subject's seizure
      log, physician observation, direct questioning and spontaneous reports. The date, number,
      duration and type of seizures any subject experiences will also be documented. In cases where
      levetiracetam is an add-on agent, we will attempt to taper the preceding medications if
      seizure control has been demonstrated. Cognitive testing will be done when subjects are not
      in a post-ictal state. Any subject who has had a seizure with generalization within 24 hours
      of their scheduled testing will be rescheduled to another day within one week.

      At week twelve, a full follow up mental status assessment will be done for the final
      assessment. Testing will be the same as that done at weeks 1 (baseline) and 4. Again,
      cognitive testing will not be done when subjects are in a post-ictal state. Any subject who
      has had a seizure with generalization within 24 hours of their scheduled testing will be
      rescheduled to the next available day, within one week.

      Follow up blood work and a screen for adverse events will also be obtained at that time.
      Again, adverse events will be assessed by review of their seizure log, physician observation,
      direct questioning and spontaneous reports. The date, number, duration and type of seizures
      will be documented.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Titration of Keppra will start at 250 mg by mouth twice daily for three days. Then 500 mg by mouth twice daily for three days. Then 750 mg by mouth twice daily for the duration of the study, or for as long as treatment is necessary. This titration schedule is subject to change based on subject's tolerability.
Other intervention name(s): Levetiracetam is the brand name for Keppra
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment