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

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

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 Overview

• Status: Recruiting
• Conditions: Epilepsy; Alzheimer Disease 3
• Intervention / Treatment: Drug: Lacosamide 100 mg; Drug: Levetiracetam 250mg

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li Feng, PhD; Phone Number: 86-13873123853; Email: fenglihx@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Li Feng, PhD; Phone Number: 86-13873123853; Email: fenglihx@163.com
      • Principal Investigator: Li Feng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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)
Experimental: 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).	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency	Record seizure frequency	At the time of enrollment
Seizure frequency	Record seizure frequency	1 month after enrollment
Seizure frequency	Record seizure frequency	3 months after enrollment
Seizure frequency	Record seizure frequency	6 months after enrollment
EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	At the time of enrollment
EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	1 month after enrollment
EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	3 months after enrollment
EEG discharge	Record interictal epileptic discharge under the 24-hour VEEG	6 months after enrollment

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Epilepsy; Alzheimer Disease; lacosamide; levetiracetam
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Epilepsy; Alzheimer Disease; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Nootropic Agents; Lacosamide; Levetiracetam
• Other Study ID Numbers: 202306123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No