Dementia, Lewy BodyPhase 4NCT02345213
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
A Phase 4 study testing E2020 in people with Dementia, Lewy Body and Lewy Body Disease, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB). Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Dementia, Lewy Body, Lewy Body Disease
- 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
- 160 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2015to 26 Mar 2018
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
- Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution
- Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
- Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26
Who cannot join
- Patients diagnosed with Parkinson's disease with dementia (PDD)
- Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
- Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
- Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
- Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).
- Conditions
- Dementia, Lewy Body, Lewy Body Disease
- Being tested
- E2020, Placebo
- Keywords
- DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2020Drug
E2020 tablets will be orally administered once daily after breakfast
PlaceboDrug
Matching placebo tablets will be orally administered once daily after breakfast
| Study group | Role | What they receive |
|---|---|---|
| E2020 | Experimental | Treatment period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-12 E2020 10 mg.
Extension period: Weeks 1-6 E2020 10 mg, After Week 7 up to week 60 E2020 10 mg. Receives: Drug: E2020 |
| Placebo | Placebo comparator | Treatment period: Weeks 1-12 placebo
Extension period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, After Week 7 up to week 60 E2020 10 mg. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse".
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start1 Mar 2015
- Primary completion15 May 2017
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, Lewy BodyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Megumi Ohdake, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345213
- Sponsor's protocol ID
- E2020-J081-419
- Status last verified
- Dec 2017
- First submitted
- 19 Jan 2015
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
- ClinicalTrials.gov ID
- NCT02345213
- Acronym / sponsor ID
- E2020-J081-419
- Conditions
- Dementia, Lewy Body, Lewy Body Disease
- Keywords
- DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 26 Jan 2015 (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 confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E2020 | Experimental | Drug: E2020Treatment period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-12 E2020 10 mg. Extension period: Weeks 1-6 E2020 10 mg, After Week 7 up to week 60 E2020 10 mg. |
| Placebo | Placebo comparator | Drug: PlaceboTreatment period: Weeks 1-12 placebo Extension period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, After Week 7 up to week 60 E2020 10 mg. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
- Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution
- Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
- Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26
Key exclusion criteria (5 listed)
- Patients diagnosed with Parkinson's disease with dementia (PDD)
- Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
- Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
- Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
- Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test
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 |
|---|---|---|
| E2020E2020 tablets will be orally administered once daily after breakfast | Drug | E2020 |
| PlaceboMatching placebo tablets will be orally administered once daily after breakfast | Drug | Placebo |
Primary outcome
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
Time frame: Up to 12 weeks
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse".
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 Jan 2019.
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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.
Megumi Ohdake study director
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E2020 in people with Dementia, Lewy Body and Lewy Body Disease, run by Eisai Co., Ltd. at 1 site 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 4 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus) (time frame: Up to 12 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 Jan 2019.