Memantine for Traumatic Brain Injury
(MEND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this pilot clinical trial is to learn whether memantine can be given safely and successfully to adults in hospital with a mild or moderate traumatic brain injury (TBI). Memantine is approved to treat Alzheimer's disease, but it is not approved to treat TBI. The study will also test whether brain scans and other assessments are suitable for a larger trial.
TBI can damage the blood-brain barrier. This protective lining controls what can pass from the bloodstream into the brain. Researchers can measure this damage with a specialized magnetic resonance imaging (MRI) scan using contrast dye.
The main questions are:
* Can participants start memantine soon after their injury and take it for three months?
* How safe and tolerable are daily memantine doses of 20 mg and 30 mg?
* Can MRI scans measure changes in the blood-brain barrier from the start of the study to three months?
* Can researchers complete the study visits and collect enough information to plan a larger trial?
The study will include 45 adults admitted to the Halifax Infirmary in Nova Scotia, Canada, with a non-penetrating mild or moderate TBI. A computer will assign each participant by chance to one of three groups. One group will receive 20 mg of memantine per day. Another group will receive 30 mg per day. The third group will receive usual care without memantine. The memantine dose will increase gradually based on how well each participant tolerates it.
Participants will:
* Receive usual care, with or without memantine for three months;
* Have specialized MRI scans near the start of the study and at three months;
* Have recordings of brain activity near the start, at three months, and at six months; and
* Complete tests and questionnaires about symptoms, memory, attention, mood, daily function, disability, and quality of life.
Researchers will compare the groups to look for differences in blood-brain barrier changes, side effects, and recovery measures. Because this is a small pilot study, it is not designed to prove that memantine improves recovery. Its results will instead help researchers choose a dose, assess safety of drug delivery, and design a larger trial.
Who Is on the Research Team?
David B Clarke, MDCM PhD
Principal Investigator
Nova Scotia Health, Dalhousie University
Ellen Parker, MD PhD
Principal Investigator
Nova Scotia Health, Dalhousie University
Mark A MacLean, MD MSc FRCSC
Principal Investigator
Nova Scotia Health, Dalhousie University
Alon Friedman, MD PhD
Principal Investigator
Dalhousie University
Are You a Good Fit for This Trial?
This trial is for adults admitted to the Halifax Infirmary with a mild or moderate traumatic brain injury (TBI) that did not break through the skull. Participants must be able to start treatment soon after their injury and take part in follow-up visits and tests.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Memantine
Trial Overview
The study is testing if memantine, a drug used for Alzheimer's disease, can be safely given at two different daily doses (20 mg or 30 mg) for three months after TBI. A third group will get usual care without memantine. Groups are chosen randomly.
How Is the Trial Designed?
3
Treatment groups
Active Control
Participants assigned to this arm will receive usual clinical care plus memantine for three months. Memantine will start at 5 mg once daily and increase no more frequently than once per week, as tolerated, to 5 mg twice daily, then 10 mg in the morning and 5 mg in the evening, and finally the target dose of 10 mg twice daily (20 mg/day). Participants who cannot tolerate a dose increase may remain at the highest tolerated dose or have the study drug temporarily reduced, interrupted, or discontinued according to the study's safety procedures. Memantine will be taken orally or, when already clinically indicated, administered through a nasogastric or orogastric tube.
Participants assigned to this arm will receive usual clinical care plus memantine for three months. Memantine will start at 5 mg once daily and increase no more frequently than once per week, as tolerated, to 5 mg twice daily, then 10 mg in the morning and 5 mg in the evening, 10 mg twice daily, 15 mg in the morning and 10 mg in the evening, and finally the target dose of 15 mg twice daily (30 mg/day). Participants who cannot tolerate a dose increase may remain at the highest tolerated dose or have the study drug temporarily reduced, interrupted, or discontinued according to the study's safety procedures. Memantine will be taken orally or, when already clinically indicated, administered through a nasogastric or orogastric tube.
Participants assigned to this arm will receive usual clinical care for traumatic brain injury. They will not receive memantine, placebo, or another study drug. Participants will complete the same scheduled study assessments and follow-up as participants in the memantine arms.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor
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