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

Central South University

Status and phase: Enrolling; Phase 4

Conditions: Epilepsy; Alzheimer Disease 3

Treatments: Drug: Levetiracetam 250mg; Drug: Lacosamide 100 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05969054

202306123

Details and patient eligibility

About

Participants will perform Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), Alzheimer's disease assessment scale-cognitive section (ADAS-Cog), Hamilton Anxiety Scale (HAMA) and Hamilton Depression Rating Scale (HAMD) evaluation. The patients will be randomly divided into two groups, treated with lacosamide and levetiracetam respectively, and maintained for 6 months.

Researchers will compare the lacosamide group with the levetiracetam group to see if the improvement of cognitive function in the two groups.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Group A: lacosamide

Experimental group

Description:

Subjects who were randomly divided into group A took lacosamide for 6 months during treatment (initial dose was 50mg bid, maintained for one week and then increased to 100mg bid and maintained at this dose)

Treatment:

Drug: Lacosamide 100 mg

Group B: levetiracetam

Experimental group

Description:

Subjects randomly divided into group B took levetiracetam for 6 months during treatment (initial dose was 250mg bid, maintained for one week and then increased to 500mg bid and maintained at this dose).

Treatment:

Drug: Levetiracetam 250mg