Mild Cognitive Impairment (MCI) Clinical Trial
Official title:
Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic 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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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