ifenprodil and Convulsive Generalized Seizure Disorder studies

Research Excerpts

Excerpt	Relevance	Reference
"Memantine suppressed generalized tonic-clonic seizures in all age groups; minimal seizures were potentiated."	1.35	Different effects of two N-methyl-D-aspartate receptor antagonists on seizures, spontaneous behavior, and motor performance in immature rats. ( Mares, P; Mikulecká, A, 2009)

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

ADAS-cog in AD With Epileptiform Activity

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (100.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Mares, P	1
Mikulecká, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase 2a Levetiracetam Trial for AD-Associated Network Hyperexcitability[NCT02002819]	Phase 2	34 participants (Actual)	Interventional	2014-10-16	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) - The ADAS-cog rating instrument (Rosen et al. 1984) will be used to evaluate the global cognitive functioning. The ADAS-cog is a 70-point scale that includes an assessment of verbal memory, language, orientation, reasoning, and praxis.The score is derived from adding point values from each of its subsections. The higher your score on the ADAS-cog, the better you do. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Blood Serum Prolactin Level

Intervention	score on a scale (Mean)
Levetiracetam (Epileptiform Activity)	-1.0
Placebo (Epileptiform Activity)	1.5

Blood samples intended for Quest Diagnostics LEV and prolactin serum levels (one 6 mL tube) will be processed in the following manner, as outlined in the Quest Diagnostics lab manual. The whole blood will be allowed to clot for 60 minutes and centrifuged at 2200 - 2500 revolutions per minute (RPM) for at least 15 minutes. The resulting serum will be split into 2 cryovials which will be stored at -20°C and immediately shipped for external assessment of LEV and prolactin levels. Prolactin will be assessed via immunoassay. The concentration of LEV in serum will be measured using validated liquid chromatography/tandem mass spectrometry (LC/MS-MS) methods. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in ADAS-cog

Intervention	ng/mL (Mean)
Levetiracetam	0.1
Placebo	0.2

Changes in Behavior and Level of Disability - ADCS-ADL

Intervention	score on a scale (Mean)
Levetiracetam	-0.2
Placebo	0.8

Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) - The ADCS-ADL rating instrument (Galasko et al. 1997) will be used to evaluate functional capacity. The ADCS-ADL is a caregiver rated questionnaire. Scores on the 24-item ADCS-ADL range from 0 to 78. A higher score indicates less severity while a lower score indicates greater severity. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in Behavior and Level of Disability - ADCS-CGIC

Intervention	score on a scale (Mean)
Levetiracetam	0.4
Placebo	0.3

ADCS-Clinical Global Impression of Change (ADCS-CGIC) - The ADCS-CGIC is a seven-point scale that gives a global rating of change from baseline (Schneider et al. 1997). The baseline and follow up assessments are based on interviews with the subject and the informant. The ADCS-CGIC is a clinician-rated measure of: global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); and global change at follow-up scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI)

Intervention	score on a scale (Mean)
Levetiracetam	4.0
Placebo	4.0

Neuropsychiatric Inventory (NPI) - The NPI (Cummings et al. 1994) will be used to evaluate the severity of behavioral symptoms. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in Cognitive Function as Measured by a Virtual Route Learning Test

Intervention	score on a scale (Mean)
Levetiracetam	-0.8
Placebo	0.2

A 20-minute computer-based virtual navigation test will be used to assess how well a subject can navigate a virtual community to reach a goal destination. The subjects will then be measured on their ability to accurately navigate the virtual community after a period of a few hours. The subject's performance after the study treatment will be compared with results from a baseline assessment done before the study treatment, using statistical tests to assess whether there was any significant change. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in Epileptiform Events

Intervention	correct turns (Mean)
No Epileptiform Activity	-6.0
Epileptic Activity	17.4

"Epileptiform activity will be measured using a 1-hr resting magnetoencephalogram/electroencephalogram (M/EEG). M/EEG can detect abnormal epileptiform findings called spikes. The M/EEG will be read by an epileptologist with specialized training to assess whether there are any spikes. If spikes are observed during the M/EEG they will be counted to determine their frequency (e.g., 5 spikes per 1 hour recording). The frequency of spikes will then be compared to baseline values from before beginning the study treatment, using statistical tests to determine if the frequency changed with treatment." (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery

Intervention	Epileptiform events (Mean)
Levetiracetam	-0.1
Placebo	-0.2

Changes in executive function were measured using the NIH EXAMINER, a 1-hour computer-based battery of various executive function tasks. The subject's performance after the study treatment will be compared with results from a baseline assessment done before the study treatment, using statistical tests to assess whether there was any significant change. The Examiner assessment consists of the following scales: antisaccade , set shifting , flanker task, dot counting, spatial 1-back, category fluency, and letter fluency. Scores for this task have an indefinite range. Higher scores however do indicate better performance. Scores for this scale were generated using item response theory. For this study, scores with SEs greater than 0.55 were classified as unreliable and excluded from analysis. Composite scores from 2 participants were excluded on this basis.The EXAMINER ranges for the participants in the study were -2.59 to 1.33. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Changes in Stroop Interference Naming

Intervention	score on a scale (Mean)
Levetiracetam	-0.06
Placebo	-0.14

Stroop Test - The Stroop Test (Stroop 1935) will be used to assess executive functions including selective attention, cognitive flexibility and processing speed. Subtasks include Stroop color naming and Stroop interference naming, and each subtask is restricted to 1 minute. The minimum score is 0 and the maximum score is 126. The higher the score the better a participant does. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Clinical Dementia Rating Sum of Boxes (CDR-SOB)

Intervention	score on a scale (Mean)
Levetiracetam	1.5
Placebo	-1.4

Clinical Dementia Rating Sum of Boxes (CDR-SOB) - The CDR will be used as a global measure of dementia severity (Morris 1993). The CDR consists of questions addressed to the caregiver/informant. The lowest score one can receive is a 0 and the highest is a 3. Score is measured by getting the mean of the individual scores in each category. Lower scores equate to less dementia severity. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

NIH EXAMINER in AD With Epileptiform Activity

Intervention	score on a scale (Mean)
Levetiracetam	0.1
Placebo	0.1

Changes in executive function will be measured using the NIH EXAMINER, a 1-hour computer-based battery of various executive function tasks. The subject's performance after the study treatment will be compared with results from a baseline assessment done before the study treatment, using statistical tests to assess whether there was any significant change. The Examiner assessment consists of the following scales: NIH EXAMINER - antisaccade , NIH EXAMINER - set shifting , NIH EXAMINER - flanker task, NIH EXAMINER - dot counting, NIH EXAMINER - spatial 1-back, NIH EXAMINER - category fluency, and NIH EXAMINER - letter fluency. Scores for this task have an indefinite range. Higher scores however do indicate better performance. Scores for this scale were generated using item response theory (Kramer et al. J Int Neuropsychol Soc. 2014;20(1):11-19. doi:10.1017/S1355617713001094). (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Standardized Assessments of Clinical Fluctuations - One Day Fluctuation Assessment Scale

Intervention	score on a scale (Mean)
No Epileptiform Activity	-0.01
Epileptiform Activity	0.22

The One Day Fluctuation Assessment Scale will be used to quantitate fluctuations of dementia symptoms (Walker et al. 2000). The One Day Fluctuation Assessment Scale has a score range of 0-21 points,with higher scores indicatingmore fluctuations. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Standardized Assessments of Clinical Fluctuations -The Clinician Assessment of Fluctuation

Intervention	score on a scale (Mean)
Levetiracetam	0.3
Placebo	-0.4

Two standardized methods will be used to quantitate fluctuations of dementia symptoms: The Clinician Assessment of Fluctuation and the One Day Fluctuation Assessment Scale (Walker et al. 2000). : The Clinician Assessment of Fluctuation (score range,0-12 points, with higher scores indicating more fluctuations),26 the One Day Fluctuation Assessment Scale (score range,0-21 points, with higher scores indicatingmore fluctuations). (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Stroop Interference in AD With Epileptiform Activity

Intervention	score on a scale (Mean)
Levetiracetam	0.9
Placebo	0.1

Stroop Test - The Stroop Test (Stroop 1935) will be used to assess executive functions including selective attention, cognitive flexibility and processing speed. Subtasks include Stroop color naming and Stroop interference naming, and each subtask is restricted to 1 minute. The minimum score is 0 and the maximum score is 126. The higher the score the better a participant does. The mean below represents the average change in score between the timepoints for all participants. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Other Studies

1 other study available for ifenprodil and Convulsive Generalized Seizure Disorder

Intervention	score on a scale (Mean)
Levetiracetam (Epileptiform Activity)	4.7
Placebo (Epileptiform Activity)	-2.6