Effects of Lacosamide and Levetiracetam on Cognitive Function in Alzheimer's Patients with Epilepsy
A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy
This study is testing whether two epilepsy medications, lacosamide and levetiracetam, can help improve thinking skills in people with Alzheimer's disease who also have epilepsy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05969054 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the cognitive improvement effects of two medications, lacosamide and levetiracetam, in patients diagnosed with Alzheimer's disease who also experience epilepsy. Participants will undergo various cognitive assessments, including the Mini-Mental State Examination and Montreal Cognitive Assessment, before being randomly assigned to receive either lacosamide or levetiracetam for a duration of six months. The study aims to compare the cognitive outcomes between the two treatment groups to determine which medication may offer greater benefits.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Alzheimer's disease who are currently on cholinesterase inhibitors and have new seizures or subclinical epileptic discharges.
Not a fit: Patients with serious medical conditions, mental illnesses, or structural brain abnormalities related to epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function in Alzheimer's patients suffering from epilepsy, potentially improving their quality of life.
How similar studies have performed: While there is ongoing research into cognitive treatments for Alzheimer's and epilepsy, this specific combination of lacosamide and levetiracetam in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan
- Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Li Feng, PhD
- Email: fenglihx@163.com
- Phone: 86-13873123853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.