Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, San Francisco University of Minnesota