Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A: lacosamide 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
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)
|
| Experimental: Group B: levetiracetam 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
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).
|
Outcome Measures
Primary Outcome Measures
- Mini-Mental State Examination (MMSE) [At the time of enrollment]
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
- Mini-Mental State Examination (MMSE) [1 month after enrollment]
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
- Mini-Mental State Examination (MMSE) [3 months after enrollment]
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
- 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) [At the time of enrollment]
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
- Montreal Cognitive Assessment (MoCA) [1 month after enrollment]
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
- Montreal Cognitive Assessment (MoCA) [3 months after enrollment]
The minimum value is 0, the maximum value is 30, the higher score 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) [At the time of enrollment]
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
- Clinical Dementia Rating (CDR) [1 month after enrollment]
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
- Clinical Dementia Rating (CDR) [3 months after enrollment]
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
- 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.
- Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale [At the time of enrollment]
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
- Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale [1 month after enrollment]
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
- Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale [3 months after enrollment]
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
- 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
- Hamilton Anxiety Scale (HAMA) [At the time of enrollment]
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
- Hamilton Anxiety Scale (HAMA) [1 month after enrollment]
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
- Hamilton Anxiety Scale (HAMA) [3 months after enrollment]
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
- 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) [At the time of enrollment]
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
- Hamilton Depression Scale (HAMD) [1 month after enrollment]
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
- Hamilton Depression Scale (HAMD) [3 months after enrollment]
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
- 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
- Seizure frequency [At the time of enrollment]
Record seizure frequency
- Seizure frequency [1 month after enrollment]
Record seizure frequency
- Seizure frequency [3 months after enrollment]
Record seizure frequency
- Seizure frequency [6 months after enrollment]
Record seizure frequency
- EEG discharge [At the time of enrollment]
Record interictal epileptic discharge under the 24-hour VEEG
- EEG discharge [1 month after enrollment]
Record interictal epileptic discharge under the 24-hour VEEG
- EEG discharge [3 months after enrollment]
Record interictal epileptic discharge under the 24-hour VEEG
- EEG discharge [6 months after enrollment]
Record interictal epileptic discharge under the 24-hour VEEG
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangya Hospital of Central South University | Changsha | Hunan | China | 410008 |
Sponsors and Collaborators
- Xiangya Hospital of Central South University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202306123