Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drexel University College of Medicine
• Collaborator: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

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.