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Acetylcholinesterase Inhibitor
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe 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
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, month 3, month 6, month 9 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, month 3, month 6, month 9 and month 12
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 moreSide effects data
From 2009 Phase 4 trial • 220 Patients • NCT001776711%
Suicide Attempt
1%
Myocardial infarcation with congestive heart failure
1%
stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
521 Previous Clinical Trials
158,859 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