Alzheimer Disease 3, Epilepsy
Conditions
Keywords
Alzheimer Disease, Epilepsy, lacosamide, levetiracetam
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.
Interventions
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)
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).
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG discharge | At the time of enrollment | Record interictal epileptic discharge under the 24-hour VEEG |
| Seizure frequency | At the time of enrollment | Record seizure frequency |
Countries
China
Contacts
Primary ContactLi Feng, PhD
Outcome results
None listed