Mild Cognitive Impairment (MCI) Clinical Trial
Official title:
Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI
Verified date | August 2012 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 144 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Aging (NIA) |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fMRI activation in medial temporal lobe regions | 2 weeks | No | |
Secondary | Memory performance as assessed in the post-scan procedure and in the neuropsychological test battery | 2 weeks | No |
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