Phase 4 N=241 Treatment

Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02787746 ↗

Enrolled (actual)

241

Serious AEs

1.2%

Results posted

Aug 2024

Primary outcome: Primary: Number of Patients With Adverse Events (AEs) — 93 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Donepezil (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Beijing Friendship Hospital
Primary completion: Jan 2019

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	—

Summary

This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02787746). 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.