The Effect of Donepezil in Radiotherapy-related Cognitive Impairment.

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of donepezil 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 donepezil.

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

Details

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

Criteria

Inclusion Criteria:

• (1) Received radiation therapy due to head and neck cancer.

• (2) Prior irradiation ≥ 1.5 years and ≤ 6 years.

• (3) Age>/= 35 years and age
• (4) Estimated life expectancy ≥ 12 months.

• (5) Cognitive impairment ≥ 4 weeks, with MMSE total score ≤26, or MoCA total score ≤ 25.

• (6) Routine laboratory studies: normal bilirubin, normal aspartate aminotransferase (AST or SGOT), normal alanine aminotransferase (ALT), normal creatinine, normal white-cell count; normal neutrophils count, normal platelets count; Hb >/=110 gram per millilitres; PT, APTT, INR in a normal range.

• (7) Constant caregivers who well understand and have willingness to sign a written informed consent document.

Exclusion Criteria:

• (1) evidence of tumor metastasis, recurrence, or invasion;

• (2) evidence of very high intracranial pressure that suggests brain hernia and need surgery;

• (3) previous treatment with donepezil or other medications for cognitive impairment;

• (4) history of mental disorders, epilepsy, cognitive impairment before radiotherapy;

• (5) history of stroke, or high risk of vascular dementia;

• (6) family history of Alzheimer's disease, Pick's disease, etc.;

• (7) history of severe head trauma;

• (8) clinically significant active disease, e.g. New York Heart Association Grade II or greater congestive heart failure, serious and inadequately controlled cardiac arrhythmia, bradycardia, significant vascular disease, severe infection;

• (9) history of allergy to relevant drugs;

• (10) pregnancy, lactation, or fertility program in the following 12 months;

• (11) participation in other experimental studies.