The Effect of Donepezil in Radiotherapy-related Cognitive Impairment.
1 other identifier
interventional
238
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 25, 2019
November 1, 2019
3.7 years
March 27, 2019
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
cognitive change
Cognitive change, which is determined by the difference value of ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) before and after the treatment of donepezil. The rating of ADAS-cog is made on 6-point scale rating from 0 to 5 in 12 domains.
Baseline to Week 24
Secondary Outcomes (4)
global condition change
Baseline to Week 24
changes of activities of daily living
Baseline to Week 24
cognition change
Baseline to Week 24
psychological statement change
Baseline to Week 24
Study Arms (2)
Donepezil
EXPERIMENTALPatients receive donepezil with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration.
Control
PLACEBO COMPARATORPatients receive placebo with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration.
Interventions
Donepezil will be used with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24).
Placebo will be used with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24).
Eligibility Criteria
You may qualify if:
- (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\</=60.
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yamei Tang, M.D.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
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
March 27, 2019
First Posted
April 9, 2019
Study Start
May 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
November 25, 2019
Record last verified: 2019-11