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Phase 2 N=96 Randomized Double-blind Basic Science

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

Mild Cognitive Impairment (MCI)

Bottom Line

View on ClinicalTrials.gov: NCT01044758 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI — -0.1203; 0.4353; -0.2238; 0.8814 mean beta coefficient

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Levetiracetam 62.5mg (Drug); Levetiracetam 125mg (Drug); Levetiracetam 250mg (Drug); Placebo (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Jul 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI		 -0.1203; 0.4353; -0.2238; 0.8814; 0.3928; 0.4825 —
SECONDARY
Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task		 38; 33; 33; 28; 34; 31 —

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).

Eligibility Criteria

Inclusion Criteria

  • All: English as a first language; right handed; able to complete written informed consent.
  • MCI subjects: In addition to above, must meet criteria for amnestic Mild Cognitive Impairment (MCI). This includes a memory complaint corroborated by an informant; impaired memory function for age and educational level; preserved general cognitive function; intact abilities of daily living; no clinical dementia.
  • Age matched Controls: Must have memory and cognitive status that is normal for their age.

Exclusion Criteria

  • Familial Alzheimer's Disease (AD) due to known genetic mutations
  • AD with Parkinsonian features; major psychiatric or behavioral disorders (e.g. depression, agitation, psychosis, manic-depressive disorder)
  • Primary or metastatic intracranial neoplasm
  • History of severe head trauma
  • Intra-cerebral hemorrhage
  • Seizure disorder
  • Hemispheric stroke
  • Presence of a progressive central nervous system disease
  • Presence of lacunar infarcts
  • Medical contraindications to MRI including cardiac pacemaker, presence of intraocular or intracranial metallic objects
  • Any known allergy to levetiracetam or behavioral problems that are a contraindication to taking Levetiracetam (e.g. agitation)
  • Prescribed use of anti-seizure medications.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01044758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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