Cognitive Impairment Clinical Trial
Official title:
The Effect of Donepezil in Radiotherapy-related Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Status | Recruiting |
Enrollment | 238 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 60 Years |
Eligibility |
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</=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. 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. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | global condition change | Efficacy of donepezil on global condition using CIBIC-plus (Clinician's Interview-Based Impression of Change plus). The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change. | Baseline to Week 24 | |
Secondary | changes of activities of daily living | Efficacy of donepezil on activities of daily living using ADL (Activities of Daily Living). Total score is from 0 to 54. The higher score, the lower impairment. | Baseline to Week 24 | |
Secondary | cognition change | Efficacy of donepezil on mental statement using MMSE (Mini Mental Status Examination). The total score of MMSE is 30. | Baseline to Week 24 | |
Secondary | psychological statement change | Efficacy of donepezil on psychological statement, including sleep disorder, mood disorder etc. using Neuropsychiatric Inventory (NPI) total score. | Baseline to Week 24 |
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