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NCT02002819 · ClinicalTrials.gov registry record · Phase 2
Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT02002819: Completed Phase 2 study, sponsored by University of Minnesota.
NCT02002819 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02002819, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory and other mental functions (referred to as cognitive functions). The seizures, and other examples of overactive electrical activity in the brain that is not noticeable, contribute to the loss of cognitive function. Studies in animal models of AD suggest that a drug that prevents seizures called levetiracetam may reduce neuronal over-excitation and improve cognition. Based on this evidence, the investigators propose to determine if levetiracetam can be used to treat patients with AD. The investigators developed novel instruments for this population that will also be used in future large-scale clinical trials. The current study will last for 12 weeks and will involve people with AD. Participants will be initially examined with an overnight brain wave study to assess for silent epileptic (seizure-like) activity. Presence of epileptic activity on the screening exam is not required to enter the trial. Participants will then be assigned to groups in a randomized manner. One group will receive levetiracetam for 4 weeks, then no drug for 4 weeks, and then placebo for 4 weeks. For another group, the order of treatments will be reversed. The cognitive abilities of participants will be retested every 4 weeks and compared to those at the beginning. The cognitive tests include a virtual-reality navigation test of memory and computerized tests of mental flexibility and problem solving. The participants will be monitored with a magnetoencephalogram (MEG) with simultaneous EEG (M/EEG) at each visit. M/EEG is a highly effective non-invasive method for identifying brain regions of epileptic activity. The investigators will need to recruit 36 randomized participants to test the study hypotheses. This study will take place at the University of California, San Francisco (UCSF) and the University of Minnesota.
Primary Outcome
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 fluen
Interventions
- DRUG levetiracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-10-16 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 2 |
What the finished NCT02002819 record still lists
NCT02002819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which levetiracetam is the first listed.
NCT02002819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02002819 about?
NCT02002819 is a clinical study titled "Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability". Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory and other mental functions (referred to as cognitive functions). The seizures, and other examples of overactive electrical activity in the brain that is not noticeable, contribute to the loss of cognitive fun...
What is the current status of trial NCT02002819?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2014-10-16. Estimated completion is 2020-07-21.
What interventions are being tested in trial NCT02002819?
The interventions under investigation include: levetiracetam (DRUG).
Who is sponsoring clinical trial NCT02002819?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02002819's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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