AGB101 for Preclinical Alzheimer's Disease
This Phase II study will test whether the investigational drug AGB101 can reduce abnormal hyperfunctional activity in the hippocampus in healthy adults who are APOE 4 carriers. APOE 4 is a genetic variant that increases a person's risk for Alzheimer's disease.
|Minimum Age||Maximum Age||Gender||Healthy Volunteers|
|55 Years||75 Years||All||Yes|
- Fluent in English
- At least 8 years of education
- Geriatric Depression Scale score less than 6
- Hachinski Ischemic Score of 4 or less
- Normal general cognitive function and normal memory function, as determined by cognitive assessments
- 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, or multiple sclerosis
- 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 more drinks per day on average)
- Unable to complete magnetic resonance imaging scans (e.g., pacemaker/defibrillator)
- Significant abnormalities in B12 or thyroid function tests
- End-stage renal disease
AGB101 is an extended-release, low-dose formulation of levetiracetam, a drug approved by the U.S. Food and Drug Administration to treat certain types of seizures. It works by decreasing abnormal excitement in the brain. In this study researchers are investigating whether the drug can reduce abnormal brain activity and improve memory.
Participants will be randomly assigned to take a capsule of the study drug (200 mg) or a placebo once daily for 2 weeks. After a 4-week washout period, participants will rotate groups and take either the study drug or a placebo for another 2 weeks.
Froedtert & The Medical College of Wisconsin
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
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- See more references