Overview

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?

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 bilirubin 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.