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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alzheimer Disease 3, Epilepsy

Intervention / Treatment
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* Drug: Lacosamide 100 mg
* Drug: Levetiracetam 250mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: lacosamide<br>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) | Drug: Lacosamide 100 mg<br>* 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)<br>|
| Experimental: Group B: levetiracetam<br>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). | Drug: Levetiracetam 250mg<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE) | The minimum value is 0, the maximum value is 30, the higher scores means a better cognition. | At the time of enrollment | 
| Mini-Mental State Examination (MMSE) | The minimum value is 0, the maximum value is 30, the higher scores means a better cognition. | 1 month after enrollment | 
| Mini-Mental State Examination (MMSE) | The minimum value is 0, the maximum value is 30, the higher scores means a better cognition. | 3 months after enrollment | 
| Mini-Mental State Examination (MMSE) | The minimum value is 0, the maximum value is 30, the higher scores means a better cognition. | 6 months after enrollment | 
| Montreal Cognitive Assessment (MoCA) | The minimum value is 0, the maximum value is 30, the higher score means a better cognition. | At the time of enrollment | 
| Montreal Cognitive Assessment (MoCA) | The minimum value is 0, the maximum value is 30, the higher score means a better cognition. | 1 month after enrollment | 
| Montreal Cognitive Assessment (MoCA) | The minimum value is 0, the maximum value is 30, the higher score means a better cognition. | 3 months after enrollment | 
| Montreal Cognitive Assessment (MoCA) | The minimum value is 0, the maximum value is 30, the higher score means a better cognition. | 6 months after enrollment | 
| Clinical Dementia Rating (CDR) | The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia. | At the time of enrollment | 
| Clinical Dementia Rating (CDR) | The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia. | 1 month after enrollment | 
| Clinical Dementia Rating (CDR) | The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia. | 3 months after enrollment | 
| Clinical Dementia Rating (CDR) | The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia. | 6 months after enrollment | 
| Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale | The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia | At the time of enrollment | 
| Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale | The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia | 1 month after enrollment | 
| Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale | The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia | 3 months after enrollment | 
| Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale | The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia | 6 months after enrollment | 
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety | At the time of enrollment | 
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety | 1 month after enrollment | 
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety | 3 months after enrollment | 
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety | 6 months after enrollment | 
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression | At the time of enrollment | 
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression | 1 month after enrollment | 
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression | 3 months after enrollment | 
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression | 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency | Record seizure frequency | At the time of enrollment | 
| Seizure frequency | Record seizure frequency | 1 month after enrollment | 
| Seizure frequency | Record seizure frequency | 3 months after enrollment | 
| Seizure frequency | Record seizure frequency | 6 months after enrollment | 
| EEG discharge | Record interictal epileptic discharge under the 24-hour VEEG | At the time of enrollment | 
| EEG discharge | Record interictal epileptic discharge under the 24-hour VEEG | 1 month after enrollment | 
| EEG discharge | Record interictal epileptic discharge under the 24-hour VEEG | 3 months after enrollment | 
| EEG discharge | Record interictal epileptic discharge under the 24-hour VEEG | 6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Epilepsy, lacosamide, levetiracetam