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Trial record 1 of 1 for:    10675135 [PUBMED-IDS]
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Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia

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ClinicalTrials.gov Identifier: NCT01318408
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : June 23, 2015
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Levetiracetam
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label
Hide Arm/Group Description All participants received study drug.
Period Title: Overall Study
Started 24
Completed 16
Not Completed 8
Arm/Group Title Open Label
Hide Arm/Group Description All participants received study drug.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
69.9
(50 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
11
  45.8%
Male
13
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title MMSE at Baseline and at Three (3) Months.
Hide Description 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.
Time Frame Baseline and Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:
All participants received study drug.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 18.2  (7.9)
Change at 3 Months 2.2  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Label
Comments The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants’ scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessing effects on cognition over time.
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title ADAS-cog at Baseline and at 3 Months.
Hide Description

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).

Time Frame Baseline and Three (3) months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:
All participants received study drug.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 25.5  (13.8)
Change at 3 months -4.3  (6.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Label
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessing cognitive effects over time.
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Lower scores (negative change) indicate improvements on the ADAS-cog.
3.Other Pre-specified Outcome
Title Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated
Hide Description Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Were Planned to be Examined.
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame 20 weeks
Adverse Event Reporting Description study was conducted for 12 weeks with an 8 week follow up
 
Arm/Group Title Open Label
Hide Arm/Group Description All participants received study drug. Four withdrew due to adverse events; related to fatigue.
All-Cause Mortality
Open Label
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label
Affected / at Risk (%)
Total   4/24 (16.67%) 
Musculoskeletal and connective tissue disorders   
fatigue   4/24 (16.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Carol Lippa, MD
Organization: Drexel University College of Medicine
Phone: 215-762-7090
Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT01318408     History of Changes
Other Study ID Numbers: KEPPRA
WIRB # 20061543 ( Other Identifier: UCB pharma grant to DUCOM )
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: February 17, 2014
Results First Posted: June 23, 2015
Last Update Posted: October 12, 2018