← Trials/Trial dossier/NCT01044758

CompletedPhase 2Results posted

Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)

Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI

Lead sponsor

Johns Hopkins University

Asset

Levetiracetam

Listed sites

Recruiting sites

Enrollment

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criteria

•Age 50-85•MRI contraindications excluded•History of intracranial hemorrhage excluded

Primary endpoint

•Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured

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

Org study IDNA_00030573

NCT IDNCT01044758

NihRC2AG036419

Timeline

Milestones

Study start2009-12 (month precision)

Study first posted2010-01-08estimated

Primary completion2012-07actual (month precision)

Study completion2012-07actual (month precision)

Last update posted2017-08-21actual

Results first posted2017-08-21actual

Assets

Drug assets

Levetiracetam

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•All: English as a first language; right handed; able to complete written informed consent.

•MCI subjects: In addition to above, must meet criteria for amnestic Mild Cognitive Impairment (MCI). This includes a memory complaint corroborated by an informant; impaired memory function for age and educational level; preserved general cognitive function; intact abilities of daily living; no clinical dementia.

•Age matched Controls: Must have memory and cognitive status that is normal for their age

Exclusion criteria

•Familial Alzheimer's Disease (AD) due to known genetic mutations

•AD with Parkinsonian features; major psychiatric or behavioral disorders (e.g. depression, agitation, psychosis, manic-depressive disorder)

•Primary or metastatic intracranial neoplasm

•History of severe head trauma

•Intra-cerebral hemorrhage

•Seizure disorder

•Hemispheric stroke

•Presence of a progressive central nervous system disease

•Presence of lacunar infarcts

•Medical contraindications to MRI including cardiac pacemaker, presence of intraocular or intracranial metallic objects

•Any known allergy to levetiracetam or behavioral problems that are a contraindication to taking Levetiracetam (e.g. agitation)

•Prescribed use of anti-seizure medications.

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

Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task

Time frame:2 weeks

descriptive

Secondary/registry result

Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task

Time frame:2 weeks

descriptive

Posted result

Group	Value (mean), percent correct recalled	Standard error
aMCI_62.5n=20 Participants	38	4
aMCI_62.5 Placebon=20 Participants	33	5
aMCI_125n=17 Participants	33	5
aMCI_125 Placebon=17 Participants	28	4
aMCI_250n=17 Participants	34	4
aMCI_250 Placebon=17 Participants	31	3
Age Matched Controln=17 Participants	44	4

Neuroimaging

2 endpoints

Primary/protocol endpoint

Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI

Time frame:2 weeks

descriptive

Primary/registry result

Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI

Time frame:2 weeks

descriptive

Posted result

Group	Value (mean), mean beta coefficient	Standard error
aMCI_62.5n=20 Participants	-0.1203	0.3475
aMCI_62.5 Placebon=20 Participants	0.4353	0.2215
aMCI_125n=17 Participants	-0.2238	0.1747
aMCI_125 Placebon=17 Participants	0.8814	0.3798
aMCI_250n=17 Participants	0.3928	0.2366
aMCI_250 Placebon=17 Participants	0.4825	0.1954
Age Matched Controln=17 Participants	-.02507	.2238

Publications (7)

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.