Alzheimer Disease 3Phase 4NCT05969054
Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy
A Phase 4 study testing Lacosamide 100 mg and Levetiracetam 250mg in people with Alzheimer Disease 3 and Epilepsy, run by Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer Disease 3, Epilepsy
- What is being tested?
- Lacosamide 100 mg and Levetiracetam 250mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Li Feng, PhD, 86-13873123853, fenglihx@163.com
Li Feng, PhD
About this study
Official title: 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.
- Conditions
- Alzheimer Disease 3, Epilepsy
- Being tested
- Lacosamide 100 mg, Levetiracetam 250mg
- Keywords
- Alzheimer Disease, Epilepsy, lacosamide, levetiracetam
- Medical subject headings
- Alzheimer disease, familial, type 3, Epilepsy, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Drug: Levetiracetam 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after enrollment
Secondary outcomes (8)
Seizure frequency
Record seizure frequency
Measured: At the time of enrollment
Seizure frequency
Record seizure frequency
Measured: 1 month after enrollment
Seizure frequency
Record seizure frequency
Measured: 3 months after enrollment
Seizure frequency
Record seizure frequency
Measured: 6 months after enrollment
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
Measured: At the time of enrollment
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
Measured: 1 month after enrollment
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
Measured: 3 months after enrollment
EEG discharge
Record interictal epileptic discharge under the 24-hour VEEG
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease 3Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Feng, MD, PhD, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969054
- Sponsor's protocol ID
- 202306123
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy
- ClinicalTrials.gov ID
- NCT05969054
- Acronym / sponsor ID
- 202306123
- Conditions
- Alzheimer Disease 3, Epilepsy
- Keywords
- Alzheimer Disease, Epilepsy, lacosamide, levetiracetam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: lacosamide | Experimental | Drug: Lacosamide 100 mgSubjects 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 B: levetiracetam | Experimental | Drug: Levetiracetam 250mgSubjects 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacosamide 100 mgSubjects 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 | Group A: lacosamide |
| Levetiracetam 250mgSubjects 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 | Group B: levetiracetam |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: At the time of enrollment
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Mini-Mental State Examination (MMSE)
Time frame: 1 month after enrollment
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
Mini-Mental State Examination (MMSE)
Time frame: 3 months after enrollment
The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
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: At the time of enrollment
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Montreal Cognitive Assessment (MoCA)
Time frame: 1 month after enrollment
The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
Montreal Cognitive Assessment (MoCA)
Time frame: 3 months after enrollment
The minimum value is 0, the maximum value is 30, the higher score 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: At the time of enrollment
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Clinical Dementia Rating (CDR)
Time frame: 1 month after enrollment
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
Clinical Dementia Rating (CDR)
Time frame: 3 months after enrollment
The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
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.
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
Time frame: At the time of enrollment
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
Time frame: 1 month after enrollment
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
Time frame: 3 months after enrollment
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
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
Hamilton Anxiety Scale (HAMA)
Time frame: At the time of enrollment
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
Time frame: 1 month after enrollment
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
Time frame: 3 months after enrollment
The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
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: At the time of enrollment
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Hamilton Depression Scale (HAMD)
Time frame: 1 month after enrollment
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
Hamilton Depression Scale (HAMD)
Time frame: 3 months after enrollment
The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
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
8 secondary outcomes
Seizure frequency
Time frame: At the time of enrollment
Seizure frequency
Time frame: 1 month after enrollment
Seizure frequency
Time frame: 3 months after enrollment
Seizure frequency
Time frame: 6 months after enrollment
EEG discharge
Time frame: At the time of enrollment
EEG discharge
Time frame: 1 month after enrollment
EEG discharge
Time frame: 3 months after enrollment
EEG discharge
Time frame: 6 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacosamide 100 mg and Levetiracetam 250mg in people with Alzheimer Disease 3 and Epilepsy, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Feng, PhD (86-13873123853, fenglihx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: At the time of enrollment). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.