Dementia With Lewy Bodies (DLB)Phase 2NCT00598650

A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

A Phase 2 study testing E2020 in people with Dementia With Lewy Bodies (DLB), run by Eisai Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Dementia With Lewy Bodies (DLB)
What is being tested?: E2020
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: Feb 2008to Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Patients who have completed Phase II double-blind study (E2020-J081-431).
Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Who cannot join

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, and/or who underwent brain surgery causing unsolved deficiency.
Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

About this study

The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).

Conditions: Dementia With Lewy Bodies (DLB)
Being tested: E2020
Keywords: Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride
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
Also called Aricept
Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.

Study groups in NCT00598650
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: E2020

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mini-mental State Examination (MMSE) Total
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.
Measured: Baseline, Week 52, and Week 52 LOCF
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.
Measured: Baseline, Week 52, and Week 52 LOCF

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Mar 2011

First posted22 Jan 2008 (estimated)
Study startFeb 2008
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dementia With Lewy Bodies (DLB)Studies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00598650
Sponsor's protocol ID: E2020-J081-432
Status last verified: Aug 2014
First submitted: 10 Jan 2008
Last updated: 3 Sep 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Not yet recruitingObservational study
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
Not yet recruiting
Rhythmic Entrainment and Alertness in Lewy Body Dementia
Dementia With Lewy Bodies (DLB), Lewy Body Dementia (LBD)
RecruitingObservational study
Multi-Center Study of Natural History in Atypical Parkinsonian Syndromes (MAPS-NH)
Multiple System Atrophy, Dementia With Lewy Bodies (DLB)
RecruitingObservational study
Biofluid Research on Age-Related or Inherited Neurodegeneration
Frontotemporal Degeneration (FTD), ALS (Amyotrophic Lateral Sclerosis)

All Dementia With Lewy Bodies (DLB) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
ClinicalTrials.gov ID: NCT00598650
Acronym / sponsor ID: E2020-J081-432
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 22 Jan 2008 (estimated)
Results: Posted 3 Sep 2014

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 evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: E2020

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Patients who have completed Phase II double-blind study (E2020-J081-431).
Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Key exclusion criteria (5 listed)

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, and/or who underwent brain surgery causing unsolved deficiency.
Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

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
E2020Also: AriceptDosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.	Drug	1

Primary outcome

Change From Baseline in Mini-mental State Examination (MMSE) Total
Time frame: Baseline, Week 52, and Week 52 LOCF
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
Time frame: Baseline, Week 52, and Week 52 LOCF
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.

Results and safety

Results posted to the registry on 3 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E2020	108	81

Primary outcome: Change From Baseline in Mini-mental State Examination (MMSE) Total

Time frame: Baseline, Week 52, and Week 52 LOCF. Mean (Standard Deviation). Unit: Score on a Scale

Measure	E2020 n = 104	Placebo/E2020 n = 28
Baseline	20.9 (5.1)	18.6 (4.7)
Week 52	0.3 (3.7)	2 (4.4)
Week 52 LOCF	0.2 (3.5)	1.7 (4.4)

Population analysed: Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.

Primary outcome: Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms

Time frame: Baseline, Week 52, and Week 52 LOCF. Mean (Standard Deviation). Unit: Score on a Scale

Measure	E2020 n = 104	Placebo/E2020 n = 28
Baseline	13.1 (16.8)	17.8 (8.2)
Week 52	-1.9 (9.8)	-4.1 (10.1)
Week 52 LOCF	-0.7 (11.1)	-4.3 (9.7)

Population analysed: Efficacy Analysis Set

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E2020	8 of 108 (7.4%)	53 of 108 (49.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dementia With Lewy Bodies (DLB)

RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Not yet recruitingObservational study
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
Not yet recruiting
Rhythmic Entrainment and Alertness in Lewy Body Dementia
Dementia With Lewy Bodies (DLB), Lewy Body Dementia (LBD)
RecruitingObservational study
Multi-Center Study of Natural History in Atypical Parkinsonian Syndromes (MAPS-NH)
Multiple System Atrophy, Dementia With Lewy Bodies (DLB)
RecruitingObservational study
Biofluid Research on Age-Related or Inherited Neurodegeneration
Frontotemporal Degeneration (FTD), ALS (Amyotrophic Lateral Sclerosis)

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.

Itaru Arimoto study director

New Product Development, Clinical Research Center, Eisai Co., Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2020 in people with Dementia With Lewy Bodies (DLB), run by Eisai Co., Ltd..

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 3 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 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Mini-mental State Examination (MMSE) Total (time frame: Baseline, Week 52, and Week 52 LOCF). 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?

On the ClinicalTrials.gov record for NCT00598650.

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 3 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.