Clinical trial NCT05969054: Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy
Official title: A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Alzheimer Disease 3
Epilepsy
Keywords: Alzheimer Disease
Epilepsy
lacosamide
levetiracetam
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: At the time of enrollment
measure: Mini-Mental State Examination (MMSE)
timeFrame: 1 month after enrollment
measure: Mini-Mental State Examination (MMSE)
timeFrame: 3 months after enrollment
measure: Mini-Mental State Examination (MMSE)
timeFrame: 6 months after enrollment
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At the time of enrollment
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 1 month after enrollment
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 3 months after enrollment
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months after enrollment
measure: Clinical Dementia Rating (CDR)
timeFrame: At the time of enrollment
measure: Clinical Dementia Rating (CDR)
timeFrame: 1 month after enrollment
measure: Clinical Dementia Rating (CDR)
timeFrame: 3 months after enrollment
measure: Clinical Dementia Rating (CDR)
timeFrame: 6 months after enrollment
measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
timeFrame: At the time of enrollment
measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
timeFrame: 1 month after enrollment
measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
timeFrame: 3 months after enrollment
measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
timeFrame: 6 months after enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: At the time of enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 1 month after enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 3 months after enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 6 months after enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: At the time of enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: 1 month after enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: 3 months after enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Seizure frequency
timeFrame: At the time of enrollment
measure: Seizure frequency
timeFrame: 1 month after enrollment
measure: Seizure frequency
timeFrame: 3 months after enrollment
measure: Seizure frequency
timeFrame: 6 months after enrollment
measure: EEG discharge
timeFrame: At the time of enrollment
measure: EEG discharge
timeFrame: 1 month after enrollment
measure: EEG discharge
timeFrame: 3 months after enrollment
measure: EEG discharge
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: