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

NCT01318408 | Completed Phase 4 Results DMC

• 2 other identifiers: KEPPRAWIRB # 20061543
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• MMSE at Baseline and at Three (3) Months.

  The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The score can range from 0 to 30, with lower scores indicating greater impairment in function.

  Baseline and Three months

• ADAS-cog at Baseline and at 3 Months.

  ADAScog (Alzheimer's Disease Assessment Scale-cognitive subscale) consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Score ranges from 0 - 70. Lower scores (negative change) indicate improvements on the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).

  Baseline and Three (3) months

Other Outcomes (1)

• Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated

  12 weeks

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Levetiracetam was titrated over 4 weeks, with initial dosing of 250 mg bis in die (BID). Dosing was flexible and was based on the prescribing physician's discretion.

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

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.

Also known as: Levetiracetam is the brand name for Keppra

Levetiracetam

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• UCB Pharma: collaborator

Study Sites (1)

Drexel University College of Medicine, Dept of Neurology

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (1)

• Ritchie K, Touchon J. Mild cognitive impairment: conceptual basis and current nosological status. Lancet. 2000 Jan 15;355(9199):225-8. doi: 10.1016/S0140-6736(99)06155-3. No abstract available.

  PMID: 10675135 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Carol Lippa, MD
• Organization: Drexel University College of Medicine

clippa@drexelmed.edu

215-762-7090

Study Officials

• Carol Lippa, MD

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 18, 2011
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 12, 2018
• Results First Posted: June 23, 2015

Record last verified: 2018-09

Locations

US (1)