Trial · NCT02002819
Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
NCT02002819, Phase 2, Completed, University of Minnesota; results first posted 2022-05-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability. Trials, record NCT02002819. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02002819
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
- NCT number
- NCT02002819
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Alzheimer's Disease
- Interventions
- levetiracetam
- First posted
- 2013-12-06
- Last updated
- 2022-05-16
- Results first posted
- 2022-05-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Secondary | Changes in Stroop Interference Naming | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Secondary | Changes in ADAS-cog | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Secondary | Clinical Dementia Rating Sum of Boxes (CDR-SOB) | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Secondary | Changes in Behavior and Level of Disability - ADCS-ADL | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Secondary | Changes in Behavior and Level of Disability - ADCS-CGIC | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Secondary | Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI) | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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). |
| Secondary | Changes in Epileptiform Events | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Other | Stroop Interference in AD With Epileptiform Activity | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
| Other | ADAS-cog in AD With Epileptiform Activity | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | score on a scale | MEAN | |
| SECONDARY | Changes in Stroop Interference Naming | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | score on a scale | MEAN | |
| SECONDARY | Changes in ADAS-cog | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | 24 participants in this study did the ADAS-cog at both baseline and treatment. | score on a scale | MEAN |
| SECONDARY | Clinical Dementia Rating Sum of Boxes (CDR-SOB) | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | score on a scale | MEAN | |
| SECONDARY | Changes in Behavior and Level of Disability - ADCS-ADL | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | score on a scale | MEAN | |
| SECONDARY | Changes in Behavior and Level of Disability - ADCS-CGIC | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | score on a scale | MEAN | |
| SECONDARY | Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI) | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | score on a scale | MEAN | |
| SECONDARY | Changes in Epileptiform Events | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | Epileptiform events | MEAN | |
| OTHER_PRE_SPECIFIED | Stroop Interference in AD With Epileptiform Activity | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | Specifically, this analysis is only looking at individuals who displayed epoileptiform activity. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | ADAS-cog in AD With Epileptiform Activity | Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment) | Specifically, this analysis is only looking at individuals who displayed epileptiform activity. | score on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery | Levetiracetam | -0.06 | 95% Confidence Interval -0.24 to 0.11 | score on a scale | |
| Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery | Placebo | -0.14 | 95% Confidence Interval -0.32 to 0.05 | score on a scale | |
| Changes in Stroop Interference Naming | Levetiracetam | 1.5 | 95% Confidence Interval -1.4 to 4.3 | score on a scale | |
| Changes in Stroop Interference Naming | Placebo | -1.4 | 95% Confidence Interval -3.6 to 0.7 | score on a scale | |
| Changes in ADAS-cog | Levetiracetam | -0.2 | 95% Confidence Interval -1.8 to 1.5 | score on a scale | |
| Changes in ADAS-cog | Placebo | 0.8 | 95% Confidence Interval -0.7 to 2.3 | score on a scale | |
| Clinical Dementia Rating Sum of Boxes (CDR-SOB) | Levetiracetam | 0.1 | 95% Confidence Interval -0.1 to 0.3 | score on a scale | |
| Clinical Dementia Rating Sum of Boxes (CDR-SOB) | Placebo | 0.1 | 95% Confidence Interval -0.2 to 0.3 | score on a scale | |
| Changes in Behavior and Level of Disability - ADCS-ADL | Levetiracetam | 0.4 | 95% Confidence Interval -0.9 to 1.6 | score on a scale | |
| Changes in Behavior and Level of Disability - ADCS-ADL | Placebo | 0.3 | 95% Confidence Interval -0.9 to 1.5 | score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levetiracetam-Placebo | 17 | |
| Overall Study | STARTED | Placebo-Levetiracetam | 17 | |
| Overall Study | COMPLETED | Levetiracetam-Placebo | 13 | |
| Overall Study | COMPLETED | Placebo-Levetiracetam | 15 | |
| Overall Study | NOT COMPLETED | Levetiracetam-Placebo | 4 | |
| Overall Study | NOT COMPLETED | Placebo-Levetiracetam | 2 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal discomfort | Gastrointestinal disorders | Levetiracetam | 1 | 34 | |
| other | Gastrointestinal discomfort | Gastrointestinal disorders | Placebo | 2 | 34 | |
| other | Headache | Nervous system disorders | Levetiracetam | 2 | 34 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 34 | |
| other | Irritability | Psychiatric disorders | Levetiracetam | 2 | 34 | |
| other | Irritability | Psychiatric disorders | Placebo | 0 | 34 | |
| other | Tiredness | Psychiatric disorders | Levetiracetam | 2 | 34 | |
| other | Tiredness | Psychiatric disorders | Placebo | 0 | 34 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam | 0 | 34 |
| Total, all-cause mortality | Placebo | 0 | 34 |
| Total, other adverse events | Levetiracetam | 7 | 34 |
| Total, other adverse events | Placebo | 5 | 34 |
| Total, serious adverse events | Levetiracetam | 0 | 34 |
| Total, serious adverse events | Placebo | 0 | 34 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Levetiracetam vs Placebo: deaths from any cause | Trial comparisons |
| Levetiracetam vs Placebo: serious adverse events | Trial comparisons |
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| Antisaccade Task | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Eriksen Flanker Task | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02002819
GET https://conductscience.org/api/trials/v1/NCT02002819/results?page=2