CompletedPhase 3

Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease

United States915 participantsStarted 2007-12-14

Plain-language 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.

Who can participate

Age range

45 Years – 91 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent from the participant (if possible) or from the participant's legal guardian or other representative at the time of the Baseline visit, prior to beginning any assessments or activities.
. Completion of study E2020-G000-326 (NCT00478205) without ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326 (NCT00478205).
. Participant must enroll in the present study within 3 days of completion of study E2020-G000-326 (NCT00478205).
. Health: physically healthy and ambulatory or ambulatory-aided (that is, walker or cane); corrected vision and hearing sufficient for compliance with testing procedures.
. Co-morbid medical conditions must be well-controlled as determined by the investigator.
. Participants undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) may be included, provided that doses are within the approved dose range as specified in the Physician's Desk Reference or local equivalent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: From the enrollment of the study up to 30 days after last dose of the study drug (up to 2 years 3 months)

Trial details

NCT IDNCT00566501

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04-01

Results submitted2012-05-16

View on ClinicalTrials.gov More Alzheimer's Disease trials

Plain-language summary

Who can participate

Age range

45 Years – 91 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent from the participant (if possible) or from the participant's legal guardian or other representative at the time of the Baseline visit, prior to beginning any assessments or activities.
. Completion of study E2020-G000-326 (NCT00478205) without ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326 (NCT00478205).
. Participant must enroll in the present study within 3 days of completion of study E2020-G000-326 (NCT00478205).
. Health: physically healthy and ambulatory or ambulatory-aided (that is, walker or cane); corrected vision and hearing sufficient for compliance with testing procedures.
. Co-morbid medical conditions must be well-controlled as determined by the investigator.
. Participants undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) may be included, provided that doses are within the approved dose range as specified in the Physician's Desk Reference or local equivalent

Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria