Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| 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 |
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| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21287 | |
| 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 May 21, 2013