Phase 4
Completed N=241
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT02787746 ↗Enrolled (actual)
241
Serious AEs
1.2%
Results posted
Aug 2024
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) — 93 Participants
◆ Published Evidence
Emerging
15citations · ~3 / year
Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease.
Summary
This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.
Linked Publications
-
Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
93 | — |
| SECONDARY Number of Patients Who Withdrew From the Trial Due to Adverse Events. |
42 | — |
| SECONDARY Changes in Mini-Mental State Examination Scores From Baseline |
18.69; 19.12; 0.44; 19.07; 0.39; 18.69 | — |
| SECONDARY Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline |
53.29; 53.71; 0.43; 53.62; 0.33; 34.76 | — |
| SECONDARY Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil |
0; 34; 5; 6; 0; 13 | 0.9744 |
| SECONDARY APOE Genotype |
1; 58; 7; 11; 1; 37 | — |
Eligibility Criteria
Inclusion Criteria
- Patients between 50 and 85 years of age.
- Patients newly diagnosed as probable AD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and National Institute of Neurologic and Communicative Disorders and Stroke-AD and Related Disorders Association (NINCDS-ADRDA) criteria; Mild to moderate AD with Mini-Mental State Examination (MMSE) 10-24, modified Hachinski ischaemic scale (MHIS)≤4, Activity of daily life scale (ADL)≥23, and Hamilton Depression Scale (HAMD) <7.
- MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2 within 6 months prior to the screening).
- 5mg daily of Donepezil for at least four weeks before the screening.
- Patient with exclusive caregiver.
- Patient should be ambulatory or ambulatory aided by a walker or cane.
- With good eyesight and hearing, can cooperate with the examination and treatment.
Exclusion Criteria
- Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
- Patients with type I diabetes, obstructive lung disease or asthma, vitamin B12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart failure, myocardial infarction, sick sinus syndrome, II-III degree atrioventricular block or heart rate<50 beats/minute [bpm]).
- Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
- Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
- Patients with a history of alcohol dependence and drug abuse.
- Patients with known hypersensitivity to medicines or foods;
- Patients taking anticholinergic agents or antihistaminic agents;
- Patients who had been hospitalized continuously for more than 3 months before the screening.
Data sourced from ClinicalTrials.gov (NCT02787746) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.