Alzheimer's Type DementiaPhase 3NCT01539031
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
A Phase 3 study testing E2020 in people with Alzheimer's Type Dementia, run by Eisai Co., Ltd. at 54 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Type Dementia
- What is being tested?
- E2020
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 54 sitesJapan
- Study dates
- Mar 2012to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- Subjects with a known history of disorders that affect cognition or the ability to assess cognition but are distinguishable from AD
- Subjects with dementia complicated by other organic disease or AD with delirium
- Known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation
- Patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary)
- Use of any prohibited prior or concomitant medications. Memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to Screening.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
Study site
Age, Saitama
Study site
Akita
Study site
Amagasaki, Hyōgo
Study site
Anan, Tokushima
Study site
Anjo, Aichi-ken
Study site
Bunkyo-ku, Tokyo
Study site
Chiba
Study site
Chikushi, Fukuoka
Study site
Fuji, Shizuoka
Study site
Fukuoka, Gunma
Study site
Fukuoka
Study site
Himeji, Hyōgo
Study site
Hiroshima
Study site
Ibaraki, Osaka
Study site
Ikeda, Osaka
Study site
Ina, Nagano
Study site
Iruma, Saitama
Study site
Izunokuni, Shizuoka
Study site
Kagoshima
Study site
Kasukabe, Saitama
Study site
Kawasaki, Kanagawa
Study site
Kida, Kagawa-ken
Study site
Kitakyushu, Fukuoka
Study site
Kitamorokata, Miyazaki
Study site
Kochi
Study site
Kodaira, Tokyo
Study site
Koto, Tokyo
Study site
Kurashiki, Okayama-ken
Study site
Kyoto
Study site
Maizuru, Kyoto
Study site
Miyoshi, Hiroshima
Study site
Morioka, Iwate
Study site
Nagaoka, Niigata
Study site
Nagasaki, Kyushu
Study site
Nara
Study site
Numakunai, Iwate
Study site
Ōbu, Aichi-ken
Study site
Osaka
Study site
Ōta-ku, Tokyo
Study site
Ōtake, Hiroshima
Study site
Sagamihara, Kanagawa
Study site
Saitama
Study site
Sakai, Osaka
Study site
Sendai, Miyagi
Study site
Sennan, Osaka
Study site
Setagaya City, Tokyo
Study site
Suginami, Tokyo
Study site
Takamatsu, Kagawa-ken
Study site
Takatsuki, Osaka
Study site
Tokorozawa, Saitama
Study site
Tokushima
Study site
Toyoake, Aichi-ken
Study site
Yokohama, Kanagawa
Study site
Yokosuka, Kanagawa
About this study
Official title: Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to 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
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.
- Conditions
- Alzheimer's Type Dementia
- Being tested
- E2020
- Keywords
- Alzheimer Disease, Dementia, Delirium, Amnestic, Cognitive Disorders, Donepezil, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders, Cholinesterase Inhibitors, Enzy
- Medical subject headings
- Alzheimer Disease, Dementia, Delirium, Cognitive Dysfunction, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2020Drug
Subjects in the Group-10 mg:
Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg
E2020Drug
Subjects in the Group-23 mg:
Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg
| Study group | Role | What they receive |
|---|---|---|
| 10 mg group | Experimental | Not described Receives: Drug: E2020 |
| 23 mg group | Active comparator | Not described Receives: Drug: E2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Severe Impairment Battery (SIB)
SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
Measured: 24 weeks
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)
CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Type DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naoki Kubota, Study director, Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539031
- Sponsor's protocol ID
- E2020-J081-343
- Status last verified
- Sep 2015
- First submitted
- 21 Feb 2012
- Last updated
- 18 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to 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
- ClinicalTrials.gov ID
- NCT01539031
- Acronym / sponsor ID
- E2020-J081-343
- Conditions
- Alzheimer's Type Dementia
- Keywords
- Alzheimer Disease, Dementia, Delirium, Amnestic, Cognitive Disorders, Donepezil, Brain Diseases, Central Nervous System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg group | Experimental | Drug: E2020 |
| 23 mg group | Active comparator | Drug: E2020 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- Subjects with a known history of disorders that affect cognition or the ability to assess cognition but are distinguishable from AD
- Subjects with dementia complicated by other organic disease or AD with delirium
- Known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation
- Patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary)
- Use of any prohibited prior or concomitant medications. Memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2020Subjects in the Group-10 mg: Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg | Drug | 10 mg group |
| E2020Subjects in the Group-23 mg: Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg | Drug | 23 mg group |
Primary outcome
The Severe Impairment Battery (SIB)
Time frame: 24 weeks
SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)
Time frame: 24 weeks
CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoki Kubota study director
Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing E2020 in people with Alzheimer's Type Dementia, run by Eisai Co., Ltd. at 54 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Severe Impairment Battery (SIB) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.