Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of D… (NCT01539031) | Clinical Trial Compass
CompletedPhase 3
Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease
Japan351 participantsStarted 2012-03
Plain-language summary
The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.
Who can participate
Age range
50 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
* Diagnosis: diagnostic evidence of probable Alzheimer's disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) 290.00 or 290.10
* Mini Mental State Examination (MMSE) less than or equal to 12 and greater than or equal to1 inclusive, at Screening
* SIB less than or equal to 90 and greater than or equal to10 at both Screening and Baseline
* No evidence of focal disease to account for dementia on any cranial image (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]).
* Subject age range: male and female subjects greater than or equal to 50 years of age inclusive
* Outpatients (patients in nursing homes are eligible)
* The subject must have a caregiver who will provide informed consent separately for his/her own participation in the study, who will have regular contact with the subject.
* Stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or equal to 3 months prior to the Screening visit
* Subjects who can swallow hole tablets, as tablets should not be broken or crushed
* Comorbid medical conditions must be clinically stable prior to Screening unless otherwise specified.
* Written informed consent will be obtained from the subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.
Exclusion Criteria
* Subjects with a known history of disorders tha…
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
1
The Severe Impairment Battery (SIB)
Timeframe: 24 weeks
2
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)