Memantine Targeting Neurovascular Dysfunction After Mild and Moderate Traumatic Brain Injury (MEND)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Acute non-penetrating TBI requiring hospital admission
Admission GCS 9-15
Injury within 24 hours of presentation
Disqualifiers
Currently pregnant or currently breastfeeding
Current incarceration or custody
Continuous use of an NMDA-R antagonist for at least 30 days before enrolment
Documented allergy or intolerance to NMDA-R antagonists prior to injury
Trial design
Design model
Parallel
Treatments tested in this trial
Memantine
DrugMemantine is a low-to-moderate affinity, non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It is approved for the symptomatic treatment of moderate to severe Alzheimer's disease but is not approved for the treatment of traumatic brain injury. By limiting excessive NMDA receptor activity, memantine may reduce processes associated with cortical spreading depolarization and blood-brain barrier dysfunction after traumatic brain injury (as has been evidenced in animal models).
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Memantine 20mg/dayActive comparator 1 intervention
Group B: Memantine 30mg/dayActive comparator 1 intervention
Group C: Usual Clinical Care Without Study DrugNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Randomized
The total number of participants randomized during the recruitment period. The prespecified feasibility target is 45 participants randomized within 24 months.
Time frame
From study opening through 24 monthsOther outcomes
1
Recruitment Rate
Recruitment rate will be calculated as the total number of participants randomized divided by the number of months that recruitment is open. The planned recruitment rate is approximately 2 participants per month.
Time frame
From study opening through 24 months2
Proportion of Eligible Participants Randomized
The number of eligible participants who are randomized divided by the total number of eligible participants identified during screening, multiplied by 100. The prespecified feasibility target is at least 50%.
Time frame
From study opening through completion of the 24-month recruitment period3
Participant Retention at the 3-Month Visit
The number of randomized participants who complete the scheduled 3-month visit divided by the total number randomized, multiplied by 100. The prespecified feasibility target is at least 75%.
Time frame
3 months after randomization4
Assigned Memantine Target-Dose Attainment
The number of participants assigned to a memantine arm who reach their assigned target dose of 20 mg/day or 30 mg/day divided by the number of participants who receive at least one dose of memantine, multiplied by 100. The highest dose reached and reasons for not reaching the assigned target dose will also be recorded.
Time frame
From first dose through 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: