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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gregory Krauss, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01044758
First received: January 7, 2010
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Mild Cognitive Impairment (MCI)
Drug: Levetiracetam
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • fMRI activation in medial temporal lobe regions [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Memory performance as assessed in the post-scan procedure and in the neuropsychological test battery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: December 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amnestic MCI Drug: Levetiracetam
50mg - 500 mg twice a day for two weeks.
Other Name: Keppra
Drug: Placebo
placebo capsule twice a day for two weeks
Placebo Comparator: Age matched control Drug: Placebo
placebo capsule twice a day for two weeks
Drug: Placebo
placebo capsule twice daily for four weeks

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 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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044758

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Gregory L Krauss, MD Johns Hopkins University
  More Information

Publications:

Responsible Party: Gregory Krauss, Professor, Neurology-Epilepsy, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01044758     History of Changes
Other Study ID Numbers: RC2AG036419, RC2AG036419
Study First Received: January 7, 2010
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Mild Cognitive Impairment
Amnestic Mild Cognitive Impairment
Functional Magnetic Resonance Imaging
Levetiracetam
Keppra
Medial Temporal Lobe
Memory Impairment
Alzheimer's Disease
AD

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 08, 2014