Effect of Memantine on Radiotherapy-related Cognitive Impairment

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Memantine

Criteria

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
• 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 bilirubinaspartate 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.