Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Levetiracetam
Intervention description: 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.
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give written informed consent

          -  Meet validated clinical criteria for Alzheimer's disease, mixed dementia or MCI

          -  Age range greater than or equal to 60 years

          -  Stable general medical condition as assessed by the investigator

          -  Seizures which are partial in onset (with or without secondary generalization)

          -  Subjects with 4 or fewer seizures per month

          -  MMSE score of less than 28 at baseline

          -  Patients who are currently being treated with anticonvulsants or those with new onset
             seizures.

        Exclusion Criteria:

          -  Patients with other clinically significant organic or neurological diseases. Patients
             considered medically unstable

          -  Patients in end stage renal disease requiring hemodialysis

          -  Patients with a known hypersensitivity to Levetiracetam

          -  Patients with primary generalized epilepsy

          -  Patients with brain tumors or other significant CNS abnormalities that are the primary
             cause of the seizures

          -  Patients with a history of status epilepticus

          -  Patients with severe psychiatric diagnoses or severe behavioral problems

          -  Dementia patients lacking a caregiver.