NCT05969054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 4, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

July 12, 2023

Last Update Submit

August 2, 2023

Conditions

Alzheimer Disease 3Epilepsy

Keywords

Alzheimer DiseaseEpilepsylacosamidelevetiracetam

Outcome Measures

Primary Outcomes (24)

  • 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 Outcomes (8)

  • Seizure frequency

    At the time of enrollment

  • Seizure frequency

    1 month after enrollment

  • Seizure frequency

    3 months after enrollment

  • Seizure frequency

    6 months after enrollment

  • EEG discharge

    At the time of enrollment

  • +3 more secondary outcomes

Study Arms (2)

Group A: lacosamide

EXPERIMENTAL

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

Group B: levetiracetam

EXPERIMENTAL

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

Interventions

Lacosamide 100 mgDRUG

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)

Group A: lacosamide
Levetiracetam 250mgDRUG

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).

Group B: levetiracetam

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Alzheimer disease, familial, type 3EpilepsyAlzheimer Disease

Interventions

LacosamideLevetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Li Feng, PhD

CONTACT

86-13873123853fenglihx@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Vice Direct of Neurology Teaching and Research Office

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 1, 2023

Study Start

July 5, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 4, 2023

Record last verified: 2023-07

Locations

CN(1)