Study Summary
This trial will test if memantine can help reduce cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors.
Eligible Conditions
- Brain Tumor
- Brain Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 1 Secondary · Reporting Duration: Up to 2 years
Month 6
Percentage of patients who attempt to take appropriate dose of memantine
Month 12
Change in cognition
Change in neurocognitive function (NCF)
Change in quantitative volumetric brain imaging
Month 6
Change in NCF
Up to 2 years
Disease-freedom from primary tumor
Overall survival
Trial Safety
Safety Progress
Side Effects for
Escitalopram and Memantine
23%Sleepiness/Sedation
10%Headache
8%Diminished Sexual Drive
8%Reduced Salivation
8%Tension/Inner Unrest
8%Concentration Difficulties
6%Orthostatic Dizziness
6%Asthenia/Lassitude/Increased Fatigability
6%Constipation
6%Polyuria/Polydipsia
4%Erectile Dysfunction
4%Nausea/Vomiting
4%Failing Memory
2%Ejaculatory Dysfunction
2%Micturtion Disturbances
2%Reduced Duration of Sleep
2%Weight Gain
2%Increased Duration of Sleep
2%Diarrhea
2%Increased Dream Activity
2%Accomodation Disturbance
2%Increased Tendancy to Sweating
Trial Design
1 Treatment Group
Prevention (memantine, CogState)
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Memantine · No Placebo Group · Phase < 1
Prevention (memantine, CogState)Experimental Group · 3 Interventions: Cogstate Assessment Battery, Memantine Hydrochloride, Memantine · Intervention Types: Behavioral, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
FDA approved
Memantine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,068 Previous Clinical Trials
41,129,282 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,917 Previous Clinical Trials
3,507,133 Total Patients Enrolled
Nadia N LaackPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
183 Total Patients Enrolled
Eligibility Criteria
Age 4 - 18 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:BILIRUBIN
No greater than 1.5 times the upper limit of normal, OR
No greater than the upper limit of normal if the total bilirubin level is greater than 1.5 times the upper limit of normal, obtained no earlier than 35 days prior to study entry.
This means that the levels of aspartate transaminase (AST) and alanine transaminase (ALT) are both less than 2.5 times the upper limit of normal.
(barrier method) during entire study period and for 4 weeks following the last dose of study medication
This is a research study for women who may become pregnant
is associated with a significant risk for subsequent radiation-induced leukoencephalopathy (RIL)
You can use the computer to take the CogState assessment battery.
is 0.7 - 1.5 mg/dL
A person's normal serum creatinine levels should be between 0.7 and 1.5 mg/dL.
If you are over 18, you need to provide informed consent
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Conditions
Cancer Related
Treatments