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Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy

Primary Purpose

Alzheimer Disease 3, Epilepsy

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lacosamide 100 mg
Levetiracetam 250mg
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease 3 focused on measuring Alzheimer Disease, Epilepsy, lacosamide, levetiracetam

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A: lacosamide

Group B: levetiracetam

Arm Description

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).

Outcomes

Primary Outcome Measures

Mini-Mental State Examination (MMSE)
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Mini-Mental State Examination (MMSE)
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Mini-Mental State Examination (MMSE)
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Mini-Mental State Examination (MMSE)
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Montreal Cognitive Assessment (MoCA)
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Montreal Cognitive Assessment (MoCA)
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Montreal Cognitive Assessment (MoCA)
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Montreal Cognitive Assessment (MoCA)
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Clinical Dementia Rating (CDR)
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Clinical Dementia Rating (CDR)
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Clinical Dementia Rating (CDR)
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Clinical Dementia Rating (CDR)
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
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
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
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
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression

Secondary Outcome Measures

Seizure frequency
Record seizure frequency
Seizure frequency
Record seizure frequency
Seizure frequency
Record seizure frequency
Seizure frequency
Record seizure frequency
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG

Full Information

First Posted
July 12, 2023
Last Updated
August 2, 2023
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05969054
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease 3, Epilepsy
Keywords
Alzheimer Disease, Epilepsy, lacosamide, levetiracetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: lacosamide
Arm Type
Experimental
Arm Description
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)
Arm Title
Group B: levetiracetam
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Lacosamide 100 mg
Intervention Description
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 Type
Drug
Intervention Name(s)
Levetiracetam 250mg
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mini-Mental State Examination (MMSE)
Description
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Time Frame
At the time of enrollment
Title
Mini-Mental State Examination (MMSE)
Description
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Time Frame
1 month after enrollment
Title
Mini-Mental State Examination (MMSE)
Description
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Time Frame
3 months after enrollment
Title
Mini-Mental State Examination (MMSE)
Description
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Time Frame
6 months after enrollment
Title
Montreal Cognitive Assessment (MoCA)
Description
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Time Frame
At the time of enrollment
Title
Montreal Cognitive Assessment (MoCA)
Description
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Time Frame
1 month after enrollment
Title
Montreal Cognitive Assessment (MoCA)
Description
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Time Frame
3 months after enrollment
Title
Montreal Cognitive Assessment (MoCA)
Description
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Time Frame
6 months after enrollment
Title
Clinical Dementia Rating (CDR)
Description
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Time Frame
At the time of enrollment
Title
Clinical Dementia Rating (CDR)
Description
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Time Frame
1 month after enrollment
Title
Clinical Dementia Rating (CDR)
Description
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Time Frame
3 months after enrollment
Title
Clinical Dementia Rating (CDR)
Description
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Time Frame
6 months after enrollment
Title
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Description
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Time Frame
At the time of enrollment
Title
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Description
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Time Frame
1 month after enrollment
Title
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Description
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Time Frame
3 months after enrollment
Title
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Description
The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
Time Frame
6 months after enrollment
Title
Hamilton Anxiety Scale (HAMA)
Description
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Time Frame
At the time of enrollment
Title
Hamilton Anxiety Scale (HAMA)
Description
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Time Frame
1 month after enrollment
Title
Hamilton Anxiety Scale (HAMA)
Description
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Time Frame
3 months after enrollment
Title
Hamilton Anxiety Scale (HAMA)
Description
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Time Frame
6 months after enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Time Frame
At the time of enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Time Frame
1 month after enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Time Frame
3 months after enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Seizure frequency
Description
Record seizure frequency
Time Frame
At the time of enrollment
Title
Seizure frequency
Description
Record seizure frequency
Time Frame
1 month after enrollment
Title
Seizure frequency
Description
Record seizure frequency
Time Frame
3 months after enrollment
Title
Seizure frequency
Description
Record seizure frequency
Time Frame
6 months after enrollment
Title
EEG discharge
Description
Record interictal epileptic discharge under the 24-hour VEEG
Time Frame
At the time of enrollment
Title
EEG discharge
Description
Record interictal epileptic discharge under the 24-hour VEEG
Time Frame
1 month after enrollment
Title
EEG discharge
Description
Record interictal epileptic discharge under the 24-hour VEEG
Time Frame
3 months after enrollment
Title
EEG discharge
Description
Record interictal epileptic discharge under the 24-hour VEEG
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Feng, PhD
Phone
86-13873123853
Email
fenglihx@163.com
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Feng, PhD
Phone
86-13873123853
Email
fenglihx@163.com
First Name & Middle Initial & Last Name & Degree
Li Feng, PhD

12. IPD Sharing Statement

Learn more about this trial

Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy

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