Effect of Memantine on Radiotherapy-related Cognitive Impairment

April 11, 2019 updated by: Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of thalidomide in radiotherapy-related cognitive impairment.

Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.

Primary outcome measure: cognitive improvement, which is determined by the difference value of ADAS-cog score before and after the treatment of memantine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Application of radiotherapy to patients with head and neck cancer isa mainstay treatment in contemporaryoncology practice. However, patients who received radiation are vulnerable to development of cognitive impairment.There is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment. We supposed that memantine, as the N-methyl-D-aspartate receptor antagonist, would relieve radiotherapy-related cognitive impairment after head and neck cancer, and would improve the life quality for these patients and their families.

Primary objectives: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of memantineon cognition in radiotherapy-related cognitive impairment.

Secondary objectives:

To evaluate the effect of memantine on sleep disorder, mood disorder, activities of daily living, and safety in patients with radiotherapy-related cognitive impairment.

OUTLINE: This is randomized, double-blind, placebo-controlled clinical trial. Patients will be enrolled and administrated with memantine or placebo. Memantine will be supplied as 10 mg per pill to be taken by mouth. Placebo will be supplied as substitute of 10 mg memantine per pill to be taken by mouth.

Patients will be screened, consented, enrolled and have a washout period for 6 weeks. Then these patients will be randomized to two arms.

Arm І: Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.

Arm ІI: Patients receive placebo with a dosage of one half pill at 8 am daily for one week (Week 1), then one half pill at 8 am and one half pill at 5 pm for one week (Week 2), then one pill at 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yamei Tang, Ph.D
        • Sub-Investigator:
          • Yi Li, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have received radiation therapy due to head and neck cancer.
  • Prior irradiation is ≥1.5 yearsand≤ 6 years.
  • Age>/= 35 years but age</=60.
  • Estimated life expectancy must be greater than 12 months.
  • Cognitive impairment exists for more than 4 weeks, withMMSE≤26, or MoCA≤25.
  • Routine laboratory studies with bilirubin </=1.0 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)< 1.0 * ULN, creatinine<1.0 * ULN, white-cell count >/= 4,000 per cubic millimeter; neutrophils count >/=1500 per cubic millimeter, platelets >/= 100,000 per cubic millimeter; Hb>/=110 gram per millilitres. PT, APTT, INR in a normal range.
  • Constant caregivers who well understand and have willingness to sign a written informed consent document.

Exclusion Criteria:

  • evidence of tumor metastasis, recurrence, or invasion;
  • evidence of very high intracranial pressure that suggests brain hernia and need surgery;
  • previous treatment with memantine or other medications for cognitive impairment;
  • history of mental disordersor cognitive impairment before radiotherapy;
  • history of stroke, or high risk of vascular dementia;
  • family history ofalzheimer's disease, pick's disease, etc.;
  • history of severe head trauma;
  • clinically significant active disease, e.g. New York Heart Association Grade II or greater congestive heart failure, serious and inadequately controlled cardiac arrhythmia, significant vascular disease, severe infection;
  • history of allergy to relevant drugs;
  • pregnancy, lactation, or fertility program in the following 12 months;
  • participation in other experimental studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: memantine
Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Drug: Memantine
Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Other Names:
  • Arm I
Placebo Comparator: placebo
Patients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Drug: Placebo
Patients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Other Names:
  • Arm II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive improvement
Time Frame: Baseline to Week 24
Cognitive improvement is determined by the difference value of ADAS-cog score before and after the treatment of memantine.
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of global condition
Time Frame: Baseline to Week 24
Improvement of global condition is determined by the difference values of CIBIC-plus before and after the treatment of memantine.
Baseline to Week 24
improvement of activities of daily living
Time Frame: Baseline to Week 24
Improvement of activities of daily living is determined by the difference values of ADL before and after the treatment of memantine.
Baseline to Week 24
improvement of activities of daily living
Time Frame: Baseline to Week 24
Improvement of activities of daily living is determined by the difference values of Clinical Dementia Rating before and after the treatment of memantine.
Baseline to Week 24
improvement of mental statement
Time Frame: Baseline to Week 24
Improvement of mental statement is determined by the difference values of MMSE before and after the treatment of memantine.
Baseline to Week 24
improvement of psychological statement, including sleep disorder, mood disorder, etc.
Time Frame: Baseline to Week 24
Improvement of psychological statement, including sleep disorder, mood disorder, etc. is determined by the difference values of Neuropsychiatric Inventory (NPI) before and after the treatment of memantine.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2017

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20161208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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