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| Name | Class |
|---|---|
| Eisai China Inc. | INDUSTRY |
| Xuanwu Hospital, Beijing | OTHER |
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This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.
This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| donepezil | Other | This is a multi-center single-arm study, which assess the safety and efficacy of donepezil in mild to moderate Alzheimer's disease in China. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil | Drug | Eligible patients were treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the dose could be reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who could not endure the 10mg/d titration the 2nd time and were put back to 5mg/d or discontinuance of Aricept® should be considered as withdrawal from the study. There were a visit (visit 1) at week 0, the end of week 4 (visit 2) and the end of week 20 (visit 3), respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Physical examinations such as vital signs and weight, clinical laboratory tests, and electrocardiograms (ECGs) during the 20 weeks. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Withdrew From the Trial Due to Adverse Events. | Number of patients who withdrew due to adverse events | 20 weeks |
| Changes in Mini-Mental State Examination Scores From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cuibai Wei, MD,PhD | Dept of Neurology, Beijing Friendship Hospital, Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31985467 | Derived | Jia J, Wei C, Chen W, Jia L, Zhou A, Wang F, Tang Y, Xu L. Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;74(1):199-211. doi: 10.3233/JAD-190940. |
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No data will be share.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil | Each enrolled patient received donepezil 10 mg/day (Aricept, two 5 mg-pills, Eisai China Inc, SuZhou, China) every night before sleeping for 20 weeks. If a patient could not tolerate 10 mg/day, the dosage for the patient could be reduced to 5 mg/day for 4 weeks and then increased back to 10 mg/day. If this patient still could not tolerate the 10 mg/day dosage and returned back to 5 mg/day or discontinued the donepezil treatment, he/she should be deemed to have quit the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil | Daily single dose of donepezil 10mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Events (AEs) | Physical examinations such as vital signs and weight, clinical laboratory tests, and electrocardiograms (ECGs) during the 20 weeks. | Posted | Count of Participants | Participants | 20 weeks |
|
|
20 weeks
Systematic assessment due to regular investigator assessment at study visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil | Daily single dose of donepezil 10mg | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jianping Jia | Department of Neurology, Xuan Wu Hospital of Capital Medical University; Freindship Hospital of Capital Medical University | +86 10 83188730 | jjp@ccmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2016 | Sep 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2016 | Sep 11, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2015 | Mar 25, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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multi-center, single-arm, open labeling clinical trial
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|
|
Comparison of Mental state examination (MMSE) scores (range 0-30) at 4 weeks and 20 weeks with baseline in mild to moderate AD patients. A higher score indicates better cognitive function.Higher score indicates better cognition function.
| Baseline, 4, 20 weeks |
| Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline | Comparison of Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scores (range 0-78) at 4 weeks and 20 weeks with baseline scores in patients with mild to moderate Alzheimer's Disease. A higher score indicates better activities of daily living (ADL). | Baseline, 4, 20 weeks |
| Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil | Comparison of incidence of adverse events among patients with different APOE genotypes | 20 weeks |
| APOE Genotype | A patient's APOE genotype (ɛ2/ɛ2, ɛ3/ɛ3, ɛ4/ɛ4, ɛ2/ɛ3, ɛ2/ɛ4 and ɛ3/e4) was tested by tested by Sanger sequencing from blood collected from the the patient at Visit 2. APOE genotype is not mandatory | 4 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Count of Participants | Participants |
|
| Heart rate | Mean | Standard Deviation | beat/min |
|
| Corrected QT interval (QTc) | Mean | Standard Deviation | msec |
|
| Aspartate aminotransferase (AST) | Mean | Standard Deviation | U/L |
|
| Past Medical history | Count of Participants | Participants |
|
| Concomitant drugs | Count of Participants | Participants |
|
| MMSE | MMSE,Mini-Mental State Examination (range 0-30). A higher score indicates better cognitive function. | Mean | Standard Deviation | score |
|
| ADCS-ADL(Alzheimer's disease cooperative study - activities of daily living) | ADCS-ADL (Alzheimer's disease cooperative study - activities of daily living) score (range 0 to 78), a higher score indicates better ADL function) | Mean | Standard Deviation | Score unit |
|
| HAMD | HAMD, Hamilton Depression Scale (score range 0 to 52). A score >7and ≤17 indicates mild depression; a score >17 and ≤24 indicates moderate depression; and a score >24 indicates severe depression. | Mean | Standard Deviation | Score unit |
|
| Previous duration of donepezil 5mg/d therapy | Mean | Standard Deviation | day |
|
|
| Secondary | Number of Patients Who Withdrew From the Trial Due to Adverse Events. | Number of patients who withdrew due to adverse events | Posted | Count of Participants | Participants | 20 weeks |
|
|
|
| Secondary | Changes in Mini-Mental State Examination Scores From Baseline | Comparison of Mental state examination (MMSE) scores (range 0-30) at 4 weeks and 20 weeks with baseline in mild to moderate AD patients. A higher score indicates better cognitive function.Higher score indicates better cognition function. | 241 patients were included in the full analysis set (FAS) and 93 patients who completed the study constituted the per-protocol set (PPS). Therefore, FAS last-observation-carried-forward [LOCF] and PPS [LOCF] included 241 and 93 patients, respectively. FAS [actual data] at baseline, Week 4 and Week 20 included 238, 145 and 94 patients, respectively. PPS [actual data] at baseline, Week 4 and Week 20 included 148, 113 and 93 patients, respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4, 20 weeks |
|
|
|
| Secondary | Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline | Comparison of Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scores (range 0-78) at 4 weeks and 20 weeks with baseline scores in patients with mild to moderate Alzheimer's Disease. A higher score indicates better activities of daily living (ADL). | 241 patients were included in the FAS and 93 patients who completed the study constituted the PPS. Therefore, FAS [LOCF] and PPS [LOCF] included 241 and 93 patients, respectively. FAS [actual data] at baseline, Week 4 and Week 20 all included 42 patients, while PPS [actual data] at baseline, Week 4 and Week 20 all included 26 patients | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4, 20 weeks |
|
|
|
| Secondary | Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil | Comparison of incidence of adverse events among patients with different APOE genotypes | 115 patients in the safety set had their APOE gene sequenced and have data on their APOE genotype. Among these patients, 1 carries APOE ɛ2/ɛ2, 58 carry APOE ɛ3/ɛ3, 7 carry APOE ɛ4/ɛ4, 11 carry APOE ɛ2/ɛ3, 1 carries APOE ɛ2/ɛ4, and 37 carry APOE ɛ3/e4. | Posted | Count of Participants | Participants | 20 weeks |
|
|
|
|
| Secondary | APOE Genotype | A patient's APOE genotype (ɛ2/ɛ2, ɛ3/ɛ3, ɛ4/ɛ4, ɛ2/ɛ3, ɛ2/ɛ4 and ɛ3/e4) was tested by tested by Sanger sequencing from blood collected from the the patient at Visit 2. APOE genotype is not mandatory | 115 patients in the study had their APOE genotype tested by Sanger sequencing from blood collected from the the patient at Visit 2. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 241 |
| 3 |
| 241 |
| 93 |
| 241 |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Hyperhomocysteinemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | Systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| hypogastralgia | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| hygrostomia | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
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| abnormal liver function | Hepatobiliary disorders | Systematic Assessment |
|
| urocystitis | Infections and infestations | Systematic Assessment |
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| shingles | Infections and infestations | Systematic Assessment |
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| upper respiratory infection | Infections and infestations | Systematic Assessment |
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| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| bacterial infection | Infections and infestations | Systematic Assessment |
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| pulmonary infection | Infections and infestations | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| thoracic injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Elevated alanine aminotransferase | Investigations | Systematic Assessment |
|
| Decreased aspartate aminotransferase | Investigations | Systematic Assessment |
|
| Decreased blood albumin | Investigations | Systematic Assessment |
|
| Elevated blood bilirubin | Investigations | Systematic Assessment |
|
| Reduced blood chloride | Investigations | Systematic Assessment |
|
| Increased blood creatine phosphokinase | Investigations | Systematic Assessment |
|
| Increased blood creatinine | Investigations | Systematic Assessment |
|
| Increased blood glucose | Investigations | Systematic Assessment |
|
| Decreased blood lactate dehydrogenase | Investigations | Systematic Assessment |
|
| Increased blood lactate dehydrogenase | Investigations | Systematic Assessment |
|
| Decreased blood sodium | Investigations | Systematic Assessment |
|
| Increased blood urea | Investigations | Systematic Assessment |
|
| Abnormal ECG | Investigations | Systematic Assessment |
|
| Abnormal EEG | Investigations | Systematic Assessment |
|
| Reduced heart rate | Investigations | Systematic Assessment |
|
| Decreased red blood cell count | Investigations | Systematic Assessment |
|
| Urinary erythrocyte positive | Investigations | Systematic Assessment |
|
| Increased white blood cell count | Investigations | Systematic Assessment |
|
| Urine leukocyte positive | Investigations | Systematic Assessment |
|
| Increased platelet count | Investigations | Systematic Assessment |
|
| Decreased blood alkaline phosphatase | Investigations | Systematic Assessment |
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| Decreased blood creatine phosphokinase | Investigations | Systematic Assessment |
|
| diabetes | Metabolism and nutrition disorders | Systematic Assessment |
|
| hyperuricemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Loss of appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperlipidemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Type 2 diabetes | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Skeletal muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Physical discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
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| Memory impairment | Nervous system disorders | Systematic Assessment |
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| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | Systematic Assessment |
|
| insomnia | Psychiatric disorders | Systematic Assessment |
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| sleep disorder | Psychiatric disorders | Systematic Assessment |
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| Amnesia | Psychiatric disorders | Systematic Assessment |
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| renal failure | Renal and urinary disorders | Systematic Assessment |
|
| hidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| skin disease | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Flushing | Vascular disorders | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
|
| FAS (actual data) |
|
|
| PPS LOCF |
|
|
| PPS (actual data) |
|
|
|
| FAS (actual data) |
|
|
| PPS LOCF |
|
|
| PPS (actual data) |
|
|
| Number of patients who did not experience adverse events |
|
| 0.3288 |
| Odds Ratio (OR) |
| 3.420 |
| 2-Sided |
| 95 |
| 0.290 |
| 40.354 |
| Other |
| Concomitant medication：Gastrointestinal drugs | Regression, Logistic | 0.5732 | Odds Ratio (OR) | 2.107 | 2-Sided | 95 | 0.158 | 28.171 | Other |
| Concomitant medication：Hypoglycemic drugs | Regression, Logistic | 0.9694 | Odds Ratio (OR) | 0.976 | 2-Sided | 95 | 0.281 | 3.387 | Other |
| Concomitant medication：Cardiovascular and Cerebrovascular drugs | Regression, Logistic | 0.0396 | Odds Ratio (OR) | 2.221 | 2-Sided | 95 | 1.039 | 4.748 | Other |
| Concomitant medication：Hepatology drugs | Regression, Logistic | 0.5889 | Odds Ratio (OR) | 2.056 | 2-Sided | 95 | 0.151 | 28.074 | Other |
| Duration of previous donepezil 5mg/d therapy (day) | Regression, Logistic | 0.1181 | Odds Ratio (OR) | 1.004 | 2-Sided | 95 | 0.999 | 1.008 | Other |
| Title |
|---|
| Measurements |
|---|
|
| APOE ɛ2/ɛ3 |
|
| APOE ɛ2/ɛ4 |
|
| APOE ɛ3/e4 |
|