Phase 2
N=26
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
APOE 4
Bottom Line
View on ClinicalTrials.gov: NCT03461861 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Functional Connectivity Strengths of Neural Networks — 0.233; 0.318 Pearson coefficient — p=0.007567
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGB101 220 mg (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Connectivity Strengths of Neural Networks |
0.233; 0.318 | 0.007567 sig |
| SECONDARY Rey Auditory Verbal Learning Test (AVLT), Delayed Recall Scaled Integer. The Higher is the Better |
108; 105 | 0.900593 |
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 adults. The investigators will compare the functional connectivity results after taking AGB101 or placebo.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03461861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.