Effect of Memantine on Radiotherapy-related Cognitive Impairment

NCT03342443 | Unknown Phase 2 DMC

• 1 other identifier: 20161208
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment

Keywords

memantine; radiotherapy-related cognitive impairment

Outcome Measures

Primary Outcomes (1)

• cognitive improvement

  Cognitive improvement is determined by the difference value of ADAS-cog score before and after the treatment of memantine.

  Baseline to Week 24

Secondary Outcomes (5)

• improvement of global condition

  Baseline to Week 24

• improvement of activities of daily living

  Baseline to Week 24

• improvement of activities of daily living

  Baseline to Week 24

• improvement of mental statement

  Baseline to Week 24

• improvement of psychological statement, including sleep disorder, mood disorder, etc.

  Baseline to Week 24

Study Arms (2)

memantine

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Memantine DRUG

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.

Also known as: Arm I

memantine

Placebo DRUG

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.

Also known as: Arm II

placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Memantine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yamei Tang, Ph.D

CONTACT

86-208-133-2620; yameitang@hotmail.com

Yi Li, Ph.D

CONTACT

86-208-133-2620; eleam2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: November 17, 2017
• Study Start: December 6, 2017
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

CN (1)