A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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)
Intervention: Lacosamide 100 mg (Drug)
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).
Intervention: Levetiracetam 250mg (Drug)
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Time Frame: 6 months after enrollment
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Mini-Mental State Examination (MMSE)
Time Frame: 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)
Time Frame: 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)
Time Frame: 6 months after enrollment
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Hamilton Anxiety Scale (HAMA)
Time Frame: 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)
Time Frame: 6 months after enrollment
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Secondary Outcomes
- EEG discharge(6 months after enrollment)
- Seizure frequency(6 months after enrollment)
Investigators
Li Feng, MD, PhD
Associate Professor Vice Direct of Neurology Teaching and Research Office
Xiangya Hospital of Central South University