LAPSE

UnknownPhase 2

Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE)

Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE) - A Phase II Exploratory Study

Lead sponsor

Walter Reed National Military Medical Center

Asset

Levetiracetam

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤26•Study partner/caregiver required

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 ID06272019

NCT IDNCT04004702

Timeline

Milestones

Study first posted2019-07-02actual

Last update posted2019-07-02actual

Study start2020-01estimated (month precision)

Primary completion2024-12estimated (month precision)

Study completion2025-06estimated (month precision)

Assets

Drug assets

Levetiracetam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Meet the National Institute of Aging-Alzheimer's Association criteria for probable AD

•Twelve-item Neuropsychiatric Inventory with score 4 or greater

•MMSE <26

•Stable doses current medications, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry

•Reliable caregiver willing and available to assist with medication administration, outcome measures

•MRI completed with no evidence of potential seizure focus as outlined in the exclusion criteria

Exclusion criteria

•Imaging suggestive of potential seizure focus or alternative cause of dementia

•Previous Epilepsy diagnosis

•Use of anti-epileptic medication for any indication within previous three months

•History of head trauma with loss of consciousness more than 30 minutes

•Alcohol/Substance abuse within 5 years of dementia onset or previous 5 years

•History of Korsakoff's syndrome

•History of encephalitis/meningitis

•Female participant who is pregnant, lactating or planning pregnancy during trial

•Scheduled elective surgery or other procedures requiring general anesthesia during the trial

•Participant with life expectancy of less than 12 months

•Any cancer requiring current chemotherapy

•Known allergy or history of previous adverse reaction to levetiracetam

•Major depression or other significant behavioral disturbance preceding Alzheimer's Disease diagnosis

•Enrollment in another clinical treatment trial

•Laboratory evidence of an alternative cause of dementia or which might preclude treatment, including untreated vitamin B12 deficiency, untreated hypothyroidism, syphilis, positive human immunodeficiency virus testing, end-stage renal disease on dialysis, significant renal impairment (creatinine clearance <75 ml/minute), or liver function tests >2x upper limit of normal within the preceding three months

Endpoints (5)

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

Behavior / neuropsychiatric

Caregiver / quality of life

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Change in Clinical Dementia Rating Sum of Boxes (CDR-SOB)

Time frame:Assessed at enrollment, week 7, week 15, week 27, and month 12

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change in Mini-Mental State Exam (MMSE)

Time frame:Assessed at enrollment, week 7, week 15, week 27, and month 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Change in Neuropsychiatric Inventory Score (NPI)

Time frame:Assessed at enrollment, week 7, week 15, week 27, and month 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Change in EuroQol 5-Dimension (EQ-5D)

Time frame:Assessed at enrollment, week 7, week 15, week 27, and month 12

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative study - Clinical Global Impression of Change (ADCS-CGIC)

Time frame:Assessed at enrollment, week 7, week 15, week 27, and month 12

change from baseline, improvement

Publications (45)

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 tableno registry results posted yet

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.