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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: lacosamide | Experimental | 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 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide 100 mg | Drug | 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency | Record seizure frequency | At the time of enrollment |
| Seizure frequency | Record seizure frequency | 1 month after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Feng, PhD | Contact | 86-13873123853 | fenglihx@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| C536598 | Alzheimer disease, familial, type 3 |
| D004827 | Epilepsy |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Levetiracetam 250mg | Drug | 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). |
|
| 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 |
| 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 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |