Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
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).
Mild Cognitive Impairment (MCI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI|
- fMRI activation in medial temporal lobe regions [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Memory performance as assessed in the post-scan procedure and in the neuropsychological test battery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Amnestic MCI||
50mg - 500 mg twice a day for two weeks.
Other Name: KeppraDrug: Placebo
placebo capsule twice a day for two weeks
|Placebo Comparator: Age matched control||
placebo capsule twice a day for two weeksDrug: Placebo
placebo capsule twice daily for four weeks
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 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. We 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.
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Gregory L Krauss, MD||Johns Hopkins University|