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

Epilepsy Clinical Trial

Official title:

A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969054
• Other study ID #: 202306123
• Status: Recruiting
• Phase: Phase 4
• Start date: July 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Xiangya Hospital of Central South University
• Contact: Li Feng, PhD
• Phone: 86-13873123853
• Email: fenglihx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease 3
• Epilepsy

Intervention

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)
• 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).

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination (MMSE)	The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.	At the time of enrollment
Primary	Mini-Mental State Examination (MMSE)	The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.	1 month after enrollment
Primary	Mini-Mental State Examination (MMSE)	The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.	3 months after enrollment
Primary	Mini-Mental State Examination (MMSE)	The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.	6 months after enrollment
Primary	Montreal Cognitive Assessment (MoCA)	The minimum value is 0, the maximum value is 30, the higher score means a better cognition.	At the time of enrollment
Primary	Montreal Cognitive Assessment (MoCA)	The minimum value is 0, the maximum value is 30, the higher score means a better cognition.	1 month after enrollment
Primary	Montreal Cognitive Assessment (MoCA)	The minimum value is 0, the maximum value is 30, the higher score means a better cognition.	3 months after enrollment
Primary	Montreal Cognitive Assessment (MoCA)	The minimum value is 0, the maximum value is 30, the higher score means a better cognition.	6 months after enrollment
Primary	Clinical Dementia Rating (CDR)	The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.	At the time of enrollment
Primary	Clinical Dementia Rating (CDR)	The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.	1 month after enrollment
Primary	Clinical Dementia Rating (CDR)	The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.	3 months after enrollment
Primary	Clinical Dementia Rating (CDR)	The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.	6 months after enrollment
Primary	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	At the time of enrollment
Primary	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	1 month after enrollment
Primary	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	3 months after enrollment
Primary	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	6 months after enrollment
Primary	Hamilton Anxiety Scale (HAMA)	The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety	At the time of enrollment
Primary	Hamilton Anxiety Scale (HAMA)	The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety	1 month after enrollment
Primary	Hamilton Anxiety Scale (HAMA)	The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety	3 months after enrollment
Primary	Hamilton Anxiety Scale (HAMA)	The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety	6 months after enrollment
Primary	Hamilton Depression Scale (HAMD)	The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression	At the time of enrollment
Primary	Hamilton Depression Scale (HAMD)	The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression	1 month after enrollment
Primary	Hamilton Depression Scale (HAMD)	The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression	3 months after enrollment
Primary	Hamilton Depression Scale (HAMD)	The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression	6 months after enrollment
Secondary	Seizure frequency	Record seizure frequency	At the time of enrollment
Secondary	Seizure frequency	Record seizure frequency	1 month after enrollment
Secondary	Seizure frequency	Record seizure frequency	3 months after enrollment
Secondary	Seizure frequency	Record seizure frequency	6 months after enrollment
Secondary	EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	At the time of enrollment
Secondary	EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	1 month after enrollment
Secondary	EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	3 months after enrollment
Secondary	EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	6 months after enrollment