NCT01044758

Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)

Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This research is being done to find out if daily use of the drug levetiracetam can improve memory function in individuals with memory problems like those associated with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD).

Detailed description

Increasing research is focused on conditions that precede the clinical diagnosis of Alzheimer's disease (AD) in order to detect patients at risk for early intervention. One such condition is mild cognitive impairment (MCI). Functional magnetic resonance imaging (fMRI) studies in this group of patients have reported increased activation in the Medial Temporal Lobe (MTL) during performance of memory tasks. The functional significance of increased activation is unclear. One possibility is that greater activity reflects the increased effort needed in order to maintain performance, and as such would be a compensatory response. An alternative possibility is that increased activation reflects aberrant physiology related to the disease process itself and as such would be a sign of greater underlying disease severity and would interfere with brain function. Data in animal models suggest the possibility that low dose levetiracetam (well-tolerated anti-convulsant) treatment may reduce the observed hyperactivity and improve memory performance among individuals with MCI. The investigators are therefore conducting a within-subjects trial of 8 weeks duration, involving 144 subjects and low dose treatment with levetiracetam. During the course of the study, each subject may receive both drug and placebo for two weeks, with the order of administering those treatments counterbalanced. Cognitive testing and fMRI imaging will be obtained after 2-weeks on drug/placebo. The overall goal of the study is to determine if treatment of MCI subjects with low dose levetiracetam reduces hyperactivity within the MTL and improves memory performance.

Conditions

• Mild Cognitive Impairment (MCI)

Interventions

Type	Name	Description
DRUG	Levetiracetam 62.5mg	62.5mg twice daily (2 weeks)
DRUG	Levetiracetam 125mg	125mg twice daily (2 weeks)
DRUG	Levetiracetam 250mg	250mg twice daily (2 weeks)
DRUG	Placebo	placebo capsule twice daily (2 weeks)

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-01-08
• Last updated: 2017-08-21
• Results posted: 2017-08-21

Locations

1 site across 1 country: United States