Status:
COMPLETED
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
APOE 4
Eligibility:
All Genders
55-75 years
Phase:
PHASE2
Brief Summary
The purpose of this project is to test the hypothesis that AGB101 low dose levetiracetam extended release formulation can reduce abnormal hyperfunctional activity in the hippocampus in normal, healthy...
Detailed Description
In this study the investigators want to find out whether the use of a perturbation, such as AGB101 low dose of levetiracetam extended release formulation, in healthy adults can reduce abnormal hippoca...
Eligibility Criteria
Inclusion
- Fluent in English
- At least eight (8) years of education
- Geriatric Depression Scale (GDS) (62) score \< 6
- Hachinski Ischemic Score ≤ 4
- Normal general cognitive function as well as 1) normal memory function, documented by MOCA score of 23 or greater, and a RBANS Delayed Memory Index score of 85 or greater.
Exclusion
- Neurological disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or a history of significant head trauma or known structural brain abnormalities
- Major psychiatric disease or chronic unstable medical conditions
- History of drug abuse
- History of alcohol abuse (4 or greater drinks per day on average)
- Unable to complete MRI scans (no Pacemaker/Defibrillator)
- Known clinically significant abnormalities in B12 or thyroid function tests
- End Stage Renal Disease (ESRD)
- Hemodialysis (HD)
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03461861
Start Date
April 11 2019
End Date
March 31 2021
Last Update
July 3 2023
Active Locations (1)
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1
Froedtert & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226