← Trials/Trial dossier/NCT03461861

CompletedPhase 2Results posted

Network-Level Mechanisms for Preclinical Alzheimer's Disease Development

Lead sponsor

Medical College of Wisconsin

Asset

Levetiracetam

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MoCA 23

Primary endpoint

•Functional Connectivity Strengths of Neural Networks

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03461861

Org study IDPRO00031146

NihR21AG056882-01

Timeline

Milestones

Study first posted2018-03-12actual

Study start2019-04-11actual

Primary completion2021-03-31actual

Study completion2021-03-31actual

Last update posted2023-07-03actual

Results first posted2023-07-03actual

Assets

Drug assets

Levetiracetam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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)

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Neuroimaging

Memory

2 endpoints

Secondary/protocol endpoint

Rey Auditory Verbal Learning Test (AVLT), Delayed Recall Scaled Integer. The Higher is the Better

Time frame:Placebo vs AGB101 2 weeks after treatment paired t-test

descriptive

Secondary/registry result

Rey Auditory Verbal Learning Test (AVLT), Delayed Recall Scaled Integer. The Higher is the Better

Time frame:Placebo vs AGB101 2 weeks after treatment paired t-test

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
AGB101 220 mgn=25 Participants	108	17
Placebon=25 Participants	105	16

Mean Difference (Final Values)3.1295% CI1.72 - 4.52p0.900593t-test, 2 sided

Neuroimaging

2 endpoints

Primary/protocol endpoint

Functional Connectivity Strengths of Neural Networks

Time frame:2 weeks after treatment between AGB101 and Placebo

descriptive

Primary/registry result

Functional Connectivity Strengths of Neural Networks

Time frame:2 weeks after treatment between AGB101 and Placebo

descriptive

Posted result

Group	Value (median), Pearson coefficient	Standard deviation
AGB101 220 mgn=25 Participants	0.233	0.132
Placebon=25 Participants	0.318	0.127

Median Difference (Final Values)-0.08395% CI-0.0886 - -0.0774p0.007567t-test, 2 sided

Publications (15)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.