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

Phase 4

Recruiting

• Conditions: Alzheimer Disease 3; Epilepsy
• Interventions: Drug: Lacosamide 100 mg; Drug: Levetiracetam 250mg

• Registration Number: NCT05969054
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-05
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: lacosamide	Lacosamide 100 mg	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)
Group B: levetiracetam	Levetiracetam 250mg	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).

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale	6 months after enrollment	The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Mini-Mental State Examination (MMSE)	6 months after enrollment	The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Montreal Cognitive Assessment (MoCA)	6 months after enrollment	The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Clinical Dementia Rating (CDR)	6 months after enrollment	The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Hamilton Anxiety Scale (HAMA)	6 months after enrollment	The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Depression Scale (HAMD)	6 months after enrollment	The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression

Secondary Outcome Measures

Name	Time	Method
Seizure frequency	6 months after enrollment	Record seizure frequency
EEG discharge	6 months after enrollment	Record interictal epileptic discharge under the 24-hour VEEG

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China