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UnknownPhase 4

Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy

A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy

Assets

Lacosamide / Levetiracetam

Listed sites

1

Recruiting sites

1

Enrollment

140

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE ≥18

Primary endpoints

•Mini-Mental State Examination (MMSE)•Montreal Cognitive Assessment (MoCA)•Clinical Dementia Rating (CDR)

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 ID202306123
NCT IDNCT05969054

Timeline

Milestones

Study start2023-07-05actual
Study first posted2023-08-01actual
Last update posted2023-08-04actual
Primary completion2025-12-31estimated
Study completion2025-12-31estimated

Assets

Drug assets

LacosamideLevetiracetam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Clinically diagnosed as Alzheimer's disease and treated with cholinesterase inhibitors;
•New seizures or subclinical epileptic discharges;
•Mini-Mental State Examination score ≥ 18 points, and/or Clinical Dementia Rating (CDR) score < 2 points;
•Sign the informed consent form

Exclusion criteria

•Suffering from syncope, transient ischemic attack, hysteria attack, migraine and other transient brain dysfunction;
•Serious medical disease (especially atrioventricular block) or mental illness;
•There are structural abnormalities related to epilepsy in other brain regions of imaging

Endpoints (32)

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
16
Behavior / neuropsychiatric
8
Fluid / digital biomarkers
4
Other clinical outcomes
4

Global cognition

16 endpoints
Primary/protocol endpoint

Mini-Mental State Examination (MMSE)

Time frame:At the time of enrollment

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Mini-Mental State Examination (MMSE)

Time frame:1 month after enrollment

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Mini-Mental State Examination (MMSE)

Time frame:3 months after enrollment

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Mini-Mental State Examination (MMSE)

Time frame:6 months after enrollment

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:At the time of enrollment

Montreal Cognitive Assessment (MoCA)

descriptive

Primary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:1 month after enrollment

Montreal Cognitive Assessment (MoCA)

descriptive

Primary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:3 months after enrollment

Montreal Cognitive Assessment (MoCA)

descriptive

Primary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:6 months after enrollment

Montreal Cognitive Assessment (MoCA)

descriptive

Primary/protocol endpoint

Clinical Dementia Rating (CDR)

Time frame:At the time of enrollment

descriptive

Primary/protocol endpoint

Clinical Dementia Rating (CDR)

Time frame:1 month after enrollment

descriptive

Primary/protocol endpoint

Clinical Dementia Rating (CDR)

Time frame:3 months after enrollment

descriptive

Primary/protocol endpoint

Clinical Dementia Rating (CDR)

Time frame:6 months after enrollment

descriptive

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale

Time frame:At the time of enrollment

ADAS-Cog

descriptive

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale

Time frame:1 month after enrollment

ADAS-Cog

descriptive

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale

Time frame:3 months after enrollment

ADAS-Cog

descriptive

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale

Time frame:6 months after enrollment

ADAS-Cog

descriptive

Behavior / neuropsychiatric

8 endpoints
Primary/protocol endpoint

Hamilton Anxiety Scale (HAMA)

Time frame:At the time of enrollment

descriptive

Primary/protocol endpoint

Hamilton Anxiety Scale (HAMA)

Time frame:1 month after enrollment

descriptive

Primary/protocol endpoint

Hamilton Anxiety Scale (HAMA)

Time frame:3 months after enrollment

descriptive

Primary/protocol endpoint

Hamilton Anxiety Scale (HAMA)

Time frame:6 months after enrollment

descriptive

Primary/protocol endpoint

Hamilton Depression Scale (HAMD)

Time frame:At the time of enrollment

descriptive

Primary/protocol endpoint

Hamilton Depression Scale (HAMD)

Time frame:1 month after enrollment

descriptive

Primary/protocol endpoint

Hamilton Depression Scale (HAMD)

Time frame:3 months after enrollment

descriptive

Primary/protocol endpoint

Hamilton Depression Scale (HAMD)

Time frame:6 months after enrollment

descriptive

Fluid / digital biomarkers

4 endpoints
Secondary/protocol endpoint

EEG discharge

Time frame:At the time of enrollment

descriptive

Secondary/protocol endpoint

EEG discharge

Time frame:1 month after enrollment

descriptive

Secondary/protocol endpoint

EEG discharge

Time frame:3 months after enrollment

descriptive

Secondary/protocol endpoint

EEG discharge

Time frame:6 months after enrollment

descriptive

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

Seizure frequency

Time frame:At the time of enrollment

event count, event

Secondary/protocol endpoint

Seizure frequency

Time frame:1 month after enrollment

event count, event

Secondary/protocol endpoint

Seizure frequency

Time frame:3 months after enrollment

event count, event

Secondary/protocol endpoint

Seizure frequency

Time frame:6 months after enrollment

event count, event

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.