Alzheimer's Type DementiaPhase 3NCT01404169
A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease
A Phase 3 study testing E2020 in people with Alzheimer's Type Dementia, run by Eisai Limited at 32 sites in China.
Trial summary
The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Type Dementia
- What is being tested?
- E2020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 32 sitesChina
- Study dates
- Sep 2011to Sep 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
- Subject age range: male and female subjects 50 to 90 years of age, inclusive
- Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- MMSE 1 to 12 inclusive, at both Screening and Baseline
- SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
- Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.
Who cannot join
- Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
- Evidence of focal disease to account for dementia on any cranial image MRI or CT.
- Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
- Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
- Illiteracy prior to AD
- Subjects who are unwilling or unable to fulfill the requirements of the study
- Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
- Subjects with a poor response (tolerability) to prior exposure to donepezil
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Beijing Anding Hospital
Beijing, Beijing Municipality
Beijing Hospital
Beijing, Beijing Municipality
Beijing Huilongguan Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Guangzhou Brain Hospital
Guangzhou, Guangdong
Guangzhou First People's Hospital
Guangzhou, Guangdong
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
The Second Hospital of Shandong University
Jinan, Shandong
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
The Second Affiliated Hospital to Nanchang University
Nanchang
Nanjing Brain Hospital
Nanjing Jiangsu
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong
Hushan Hospital affliated to Fudan University
Shanghai, Shanghai Municipality
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality
Tianjin Anding Hospital
Tianjin
Tianjin People's Hospital
Tianjin
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei
Union Hospital, Tongji Medical college Huazhong University of Science and Technology
Wuhan, Hubei
Tangdu Hospital, The Fourth Military Medical University
Xi’an, Shanxi
Xi'An Mental Health Center
Xi’an, Shanxi
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi
The First People's Hospital of YueYang
Yueyang, Hunan
About this study
The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.
- Conditions
- Alzheimer's Type Dementia
- Being tested
- E2020, Placebo
- 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
In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.
PlaceboDrug
Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E2020 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the total Severe Impairment Battery (SIB) score at Week 24
All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.
Measured: 24 weeks
Secondary outcomes (1)
Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
An ANCOVA with embedded Cochran-Mantel-Haenszel (CMH) test will be used with the CIBIC+ and center in the model. Overall change from Baseline in scores at Week 24 (LOCF) will be analyzed with the same model as the SIB.
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 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2014
- Study completionSep 2014
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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- 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 Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404169
- Sponsor's protocol ID
- E2020-C086-339
- Status last verified
- Mar 2017
- First submitted
- 26 Jul 2011
- Last updated
- 8 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01404169
- Acronym / sponsor ID
- E2020-C086-339
- 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
- 260 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jul 2011 (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 objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects 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 |
|---|---|---|
| 1 | Experimental | Drug: E2020 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
- Subject age range: male and female subjects 50 to 90 years of age, inclusive
- Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- MMSE 1 to 12 inclusive, at both Screening and Baseline
- SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
Key exclusion criteria (8 listed)
- Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
- Evidence of focal disease to account for dementia on any cranial image MRI or CT.
- Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
- Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
- Illiteracy prior to AD
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 |
|---|---|---|
| E2020In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period. | Drug | 1 |
| PlaceboPlacebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks. | Drug | 2 |
Primary outcome
The change in the total Severe Impairment Battery (SIB) score at Week 24
Time frame: 24 weeks
All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.
1 secondary outcome
Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
Time frame: 24 weeks
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 8 Mar 2017.
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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 Co., Ltd.
32 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 Limited at 32 sites in China.
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 6 inclusion and 8 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 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. 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. Some participants in this study may receive a placebo. 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 change in the total Severe Impairment Battery (SIB) score at Week 24 (time frame: 24 weeks). 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 8 Mar 2017.