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Acetylcholinesterase Inhibitor

Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) for Alzheimer's Disease

Phase 3
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, month 3, month 6, month 9 and month 12
Awards & highlights

Summary

The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, month 3, month 6, month 9 and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, month 3, month 6, month 9 and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events (AEs)
Secondary study objectives
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Total Score
Change From Baseline in Mini-Mental State Examination (MMSE) Total Score
Change From Baseline in Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Severe Scale (ADCS-ADL) Total Score
+8 more

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671
1%
Suicide Attempt
1%
Myocardial infarcation with congestive heart failure
1%
stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)Experimental Treatment1 Intervention
Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).
Group II: Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)Experimental Treatment1 Intervention
Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg immediate release (IR) in the preceding double-blind study E2020-G000-326 (NCT00478205).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donepezil
FDA approved

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
520 Previous Clinical Trials
158,713 Total Patients Enrolled
Eisai LimitedIndustry Sponsor
62 Previous Clinical Trials
13,353 Total Patients Enrolled
Jane Yardley, Ph.DStudy DirectorEisai Limited
1 Previous Clinical Trials
1,467 Total Patients Enrolled
~52 spots leftby Sep 2025
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