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LEV-AD
CompletedPhase 2Results postedLevetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
Phase 2a Levetiracetam Trial for AD-Associated Network Hyperexcitability
Lead sponsor
Asset
Levetiracetam
Listed sites
2
Recruiting sites
-
Enrollment
34
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE ≥18
Primary endpoint
•Changes in Executive Function
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
To be included in the trial all of the following inclusion criteria must be met:
Ability to obtain written informed consent from the patient or caregiver as a surrogate; Meets National Institute on Aging-Alzheimer's Association Workgroups criteria for probable AD dementia (McKhann et al. 2011); Age ≤ 80 years at time of screening; Willing and able caregiver who has daily contact with the subject; Mini-Mental State Examination (MMSE) score ≥ 18 and/or Clinical Dementia Rating (CDR) < 2 at the initial screening assessment; Subjects and caregivers must be able to comply with prescribed regime of study treatment throughout the course of the study, and meet the required time commitment of four days of in-person visits; Any concurrent treatment for AD approved by the Food and Drug Administration (FDA), such as donepezil, galantamine, or rivastigmine, and memantine, must be stable for at least 30 days prior to screening and at least 60 days prior to study day 1. Other medications (except those listed under exclusion criteria) are allowed as long as the dose is stable for 30 days prior to screening
Exclusion criteria
Any conditions which could account for cognitive deficits in addition to AD, including but not limited to Vitamin B12 or folate deficiency, abnormal thyroid function, posttraumatic conditions, syphilis, multiple sclerosis or another neuroinflammatory disorder, Parkinson's disease, vascular or multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, central nervous system (CNS) tumor, progressive supranuclear palsy, subdural hematoma, etc.; Previous history of a seizure disorder, excepting cases where the first seizure or detection of epileptiform activity was within 5 years of screening and the patient is not prescribed an anticonvulsant; Significant systemic medical illnesses; Use of medications likely to affect CNS functions (e.g., benzodiazepines, narcotics); Severe renal dysfunction with creatine clearance < 30 ml/min, which would affect serum LEV levels; Participation in another AD clinical trial within 3 months of Screening, or any AD clinical trial, such as a vaccine, that has potential long-term effects; Treatment with another study drug or investigational drug within 30 days of Screening; Pregnant or lactating; Any other medical condition which is determined by the investigators to potentially create an undue risk for an adverse effect; Biomarker evidence unsupportive of a diagnosis of AD.
Endpoints (34)
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
Global cognition
8 endpointsChanges in ADAS-cog
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
ADAS-Cog
descriptive
Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
categorical status, descriptive
Changes in ADAS-cog
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
ADAS-Cog
descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=24 Participants | -0.2 | --1.8 - 1.5 |
| Placebon=24 Participants | 0.8 | --0.7 - 2.3 |
Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
categorical status, descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=28 Participants | 0.1 | --0.1 - 0.3 |
| Placebon=28 Participants | 0.1 | --0.2 - 0.3 |
ADAS-cog in AD With Epileptiform Activity
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
ADAS-Cog
descriptive
Changes in Cognitive Function as Measured by a Virtual Route Learning Test
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
ADAS-cog in AD With Epileptiform Activity
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
ADAS-Cog
descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| Levetiracetam (Epileptiform Activity)n=9 Participants | -1.0 | 4.1 |
| Placebo (Epileptiform Activity)n=9 Participants | 1.5 | 4.5 |
Changes in Cognitive Function as Measured by a Virtual Route Learning Test
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Posted result
| Group | Value (mean), correct turns | Reported bounds |
|---|---|---|
| No Epileptiform Activityn=7 Participants | -6.0 | --21.4 - 9.4 |
| Epileptic Activityn=5 Participants | 17.4 | --0.6 - 35.4 |
Executive function / language
10 endpointsChanges in Executive Function as Measured by the NIH EXAMINER Computer Battery
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
categorical status, descriptive
Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
categorical status, descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=22 Participants | -0.06 | --0.24 - 0.11 |
| Placebon=22 Participants | -0.14 | --0.32 - 0.05 |
Changes in Stroop Interference Naming
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Changes in Stroop Interference Naming
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=22 Participants | 1.5 | --1.4 - 4.3 |
| Placebon=22 Participants | -1.4 | --3.6 - 0.7 |
Stroop Interference in AD With Epileptiform Activity
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
change from baseline, improvement
NIH EXAMINER in AD With Epileptiform Activity
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
categorical status, descriptive
MEG Power Spectrum Measures
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
event count, event
Stroop Interference in AD With Epileptiform Activity
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| Levetiracetam (Epileptiform Activity)n=9 Participants | 4.7 | 7.2 |
| Placebo (Epileptiform Activity)n=9 Participants | -2.6 | 5.0 |
NIH EXAMINER in AD With Epileptiform Activity
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
categorical status, descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| No Epileptiform Activityn=14 Participants | -0.01 | --0.39 - 0.37 |
| Epileptiform Activityn=8 Participants | 0.22 | --0.05 - 0.49 |
MEG Power Spectrum Measures
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
event count, event
Function / daily living
2 endpointsChanges in Behavior and Level of Disability - ADCS-ADL
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
ADCS-Activities of Daily Living (ADCS-ADL)
descriptive
Changes in Behavior and Level of Disability - ADCS-ADL
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
ADCS-Activities of Daily Living (ADCS-ADL)
descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=28 Participants | 0.4 | --0.9 - 1.6 |
| Placebon=28 Participants | 0.3 | --0.9 - 1.5 |
Behavior / neuropsychiatric
4 endpointsChanges in Behavior and Level of Disability - ADCS-CGIC
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
change from baseline, improvement
Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI)
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
Neuropsychiatric Inventory (NPI)
descriptive
Changes in Behavior and Level of Disability - ADCS-CGIC
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=28 Participants | 4.0 | -3.8 - 4.3 |
| Placebon=28 Participants | 4.0 | -3.7 - 4.3 |
Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI)
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
Neuropsychiatric Inventory (NPI)
descriptive
Posted result
| Group | Value (mean), score on a scale | Reported bounds |
|---|---|---|
| Levetiracetamn=28 Participants | -0.8 | --2.7 - 1.2 |
| Placebon=28 Participants | 0.2 | --2.2 - 2.6 |
Neuroimaging
2 endpointsMEG Functional Connectivity Measures
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
MEG Functional Connectivity Measures
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Fluid / digital biomarkers
2 endpointsChanges in Epileptiform Events
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
event count, event
Changes in Epileptiform Events
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
event count, event
Posted result
| Group | Value (mean), Epileptiform events | Reported bounds |
|---|---|---|
| Levetiracetamn=9 Participants | -0.1 | --0.4 - 0.1 |
| Placebon=9 Participants | -0.2 | --1.1 - 0.6 |
Other (unclassified)
6 endpointsStandardized Assessments of Clinical Fluctuations -The Clinician Assessment of Fluctuation
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Blood Serum Prolactin Level
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
concentration, descriptive
Standardized Assessments of Clinical Fluctuations - One Day Fluctuation Assessment Scale
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Standardized Assessments of Clinical Fluctuations -The Clinician Assessment of Fluctuation
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| Levetiracetamn=28 Participants | 0.9 | 2.6 |
| Placebon=28 Participants | 0.1 | 3.4 |
Blood Serum Prolactin Level
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
concentration, descriptive
Posted result
| Group | Value (mean), ng/mL | Standard deviation |
|---|---|---|
| Levetiracetamn=24 Participants | 0.1 | 1.9 |
| Placebon=24 Participants | 0.2 | 1.5 |
Standardized Assessments of Clinical Fluctuations - One Day Fluctuation Assessment Scale
Time frame:Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)
descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| Levetiracetamn=28 Participants | 0.3 | 1.8 |
| Placebon=28 Participants | -0.4 | 1.6 |
Publications (16)
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
- PMID3780608via BACKGROUND
- PMID21861988via BACKGROUND
- PMID9236950via BACKGROUND
- PMID9236949via BACKGROUND
- PMID22869752via BACKGROUND
- PMID23835471via BACKGROUND
- PMID22541439via BACKGROUND
- PMID18786655via BACKGROUND
- PMID7991117via BACKGROUND
- PMID8232972via BACKGROUND
- PMID6496779via BACKGROUND
- PMID11040887via BACKGROUND
- PMID34570177via DERIVED
- PMID17478722via BACKGROUND
- PMID33973646via DERIVED
- PMID22578498via BACKGROUND
Provenance
Sources
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.