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Memantine for Cognitive Impairment After Radiation Therapy in Pediatric Brain Cancer

Phase < 1
Waitlist Available
Led By Nadia N. Laack, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving intracranial radiation for a primary central nervous system (CNS) malignancy
Histological or radiologic confirmation of intracranial disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test if memantine can help reduce cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors.

Who is the study for?
This trial is for pediatric patients with central nervous system tumors who are undergoing radiation therapy. They must have confirmed brain disease, be able to perform computer-based cognitive tests, and have normal organ function. It's not for those with certain high-grade tumors, previous brain radiation, memantine allergies, frequent seizures despite medication, or severe concurrent illnesses.Check my eligibility
What is being tested?
The study is testing whether memantine hydrochloride can help reduce memory and thinking problems in children after they've had radiation treatment for brain tumors. Participants will also undergo cognitive assessments using the Cogstate battery.See study design
What are the potential side effects?
While specific side effects of memantine in this trial context aren't listed, common ones include dizziness, headache, confusion and constipation. The drug may interact with other medications like benzodiazepines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am undergoing brain radiation for a primary brain cancer.
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My brain disease has been confirmed by tests.
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I am over 18 and can consent, or if 7-17, I have my guardian's consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Percentage of patients who attempt to take appropriate dose of memantine
Other outcome measures
Change in NCF
Change in cognition
Change in neurocognitive function (NCF)
+3 more

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (memantine, CogState)Experimental Treatment3 Interventions
Patients receive memantine PO BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine Hydrochloride
2018
Completed Phase 2
~170
Memantine
2006
Completed Phase 4
~1200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,178 Previous Clinical Trials
3,758,383 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,287 Total Patients Enrolled
Nadia N. Laack, M.D.Principal InvestigatorMayo Clinic
2 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Memantine Clinical Trial Eligibility Overview. Trial Name: NCT04217694 — Phase < 1
Brain Tumor Research Study Groups: Prevention (memantine, CogState)
Brain Tumor Clinical Trial 2023: Memantine Highlights & Side Effects. Trial Name: NCT04217694 — Phase < 1
Memantine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04217694 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prior experiments that have utilized Memantine?

"Currently, 24 medical trials are in progress involving Memantine with 11 of them being Phase 3. Most research is taking place around Ypsilanti, Michigan; however, there are 308 separate sites conducting the study across the US."

Answered by AI

How many individuals can participate in this clinical trial?

"Affirmative, the information on clinicaltrials.gov confirms that this experiment is actively recruiting patients. It was first shared to the public on February 17th 2020 and has been updated as recently June 3rd 2022. 20 individuals are being accepted at one medical site for participation in this trial."

Answered by AI

Do individuals aged sixty or older fulfill the requirements for participation in this experiment?

"For this research initiative, those aged 4 to 18 are eligible for enrolment."

Answered by AI

Is there currently an opportunity for patients to participate in this trial?

"According to the details available on clinicaltrials.gov, this research is actively searching for participants; it was first announced in February of 2020 and its most recent update occurred June 3rd 2022."

Answered by AI

What are the eligibility criteria for participation in this clinical trial?

"To meet the qualifications for this medical trial, candidates need to have cancer and must be between 4-18 years old. The study is targeting 20 subjects in total."

Answered by AI
~1 spots leftby Jun 2024