Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia
Information source: Drexel University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy & Cognitively Impaired Elderly
Intervention: Levetiracetam (Drug)
Phase: Phase 4
Sponsored by: Drexel University College of Medicine
Official(s) and/or principal investigator(s):
Carol Lippa, MD, Principal Investigator, Affiliation: Drexel University College of Medicine
Carol Lippa, MD, Phone: 215-762-7090, Email: firstname.lastname@example.org
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.
Official title: A Prospective, Phase 4, Open-Label, Twelve-Week Study to Examine the Cognitive Impact and Tolerability of Levetiracetam (Keppra) in Elderly Patients With Seizures of Partial Onset
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary measures of interest are the cognitive and mini-mental state exam scores, number of seizure episodes assessed across time. In addition, several ratings such as activities of daily living, behavior and motor activity will also be evaluated.
Secondary outcome: Several ratings such as activities of daily living, behavior and motor activity will also be evaluated.
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 mediciations. Baseline history and a physical and neurolgical 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
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.
Minimum age: 60 Years.
Maximum age: 90 Years.
- Able to give written informed consent
- Meet validated clinical criteria for Alzheimer's disease, mixed dementia or MCI
- Age range greaeter than or equal to 60 years
- Stable general meddical 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
- 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.
Locations and Contacts
Carol Lippa, MD, Phone: 215-762-7090, Email: email@example.com
Drexel University College of Medicine, Dept of Neurology, Philadelphia, Pennsylvania 19102, United States; Recruiting
Marjorie Hepler, RN, BSN, Phone: 215-762-7783, Email: firstname.lastname@example.org
Andrea Rosso, MPH, Phone: 215-762-1776, Email: email@example.com
Ritchie K, Touchon J. Mild cognitive impairment: conceptual basis and current nosological status. Lancet. 2000 Jan 15;355(9199):225-8. No abstract available.
Starting date: January 2008
Last updated: May 24, 2011