Trial Outcomes & Findings for Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia (NCT NCT01318408)
NCT ID: NCT01318408
Last Updated: 2018-10-12
Results Overview
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.
COMPLETED
PHASE4
24 participants
Baseline and Three months
2018-10-12
Participant Flow
Participant milestones
| Measure |
Open Label
All participants received study drug.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia
Baseline characteristics by cohort
| Measure |
Open Label
n=24 Participants
All participants received study drug.
|
|---|---|
|
Age, Continuous
|
69.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Three monthsThe 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.
Outcome measures
| Measure |
Open Label
n=24 Participants
All participants received study drug.
|
|---|---|
|
MMSE at Baseline and at Three (3) Months.
Baseline
|
18.2 units on a scale
Standard Deviation 7.9
|
|
MMSE at Baseline and at Three (3) Months.
Change at 3 Months
|
2.2 units on a scale
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Baseline and Three (3) monthsADAScog (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).
Outcome measures
| Measure |
Open Label
n=24 Participants
All participants received study drug.
|
|---|---|
|
ADAS-cog at Baseline and at 3 Months.
Baseline
|
25.5 units on a scale
Standard Deviation 13.8
|
|
ADAS-cog at Baseline and at 3 Months.
Change at 3 months
|
-4.3 units on a scale
Standard Deviation 6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksSeveral Ratings Such as Activities of Daily Living, Behavior and Motor Activity Were Planned to be Examined.
Outcome measures
Outcome data not reported
Adverse Events
Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label
n=24 participants at risk
All participants received study drug. Four withdrew due to adverse events; related to fatigue.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
fatigue
|
16.7%
4/24 • 20 weeks
study was conducted for 12 weeks with an 8 week follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place