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AGB101 for Preclinical Alzheimer's Disease

Recruiting

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
April 11, 2019
March 31, 2020
50

  • 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
  • Dialysis

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.

Name City State Zip Status Primary Contact
Froedtert & The Medical College of Wisconsin
Milwaukee Wisconsin 53226 Recruiting Shelby Schold
414-955-0698
sschold@mcw.edu

Medical College of Wisconsin

  • National Institute on Aging (NIA)

Name Role Affiliation
Shi-Jiang Li, PhD Principal Investigator The Medical College of Wisconsin

Name Phone Email
Shelby Schold 414-955-0698 sschold@mcw.edu
Barbara Blaney 414-955-0609 bblaney@mcw.edu

NCT03461861

Network-Level Mechanisms for Preclinical Alzheimer's Disease Development