Trial · NCT01278407

A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

NCT01278407, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2015-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase. Trials, record NCT01278407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01278407

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
NCT number: NCT01278407
Status: Completed
Phases: Phase 3
Enrollment: 142 participants, actual
Lead sponsor: Eisai Co., Ltd.
Conditions: Dementia With Lewy Bodies (DLB)
Interventions: Donepezil 5 mg, Donepezil 10 mg, Donepezil matched placebo
First posted: 2011-01-17
Last updated: 2023-06-29
Results first posted: 2015-11-30

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mini-Mental State Examination (MMSE) Score	Week 12 for Confirmatory Phase	The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.
Primary	Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score	Week 12 for Confirmatory Phase	The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation \[reported as cognitive fluctuation inventory\]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mini-Mental State Examination (MMSE) Score	Week 12 for Confirmatory Phase	Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.	Units on a scale	MEAN
PRIMARY	Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score	Week 12 for Confirmatory Phase	Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Mini-Mental State Examination (MMSE) Score	Placebo - Confirmatory Phase	0.6	Standard Deviation 3.0	Units on a scale
Change From Baseline in Mini-Mental State Examination (MMSE) Score	Donepezil 5 mg - Confirmatory Phase	1.4	Standard Deviation 3.4	Units on a scale
Change From Baseline in Mini-Mental State Examination (MMSE) Score	Donepezil 10 mg - Confirmatory Phase	2.2	Standard Deviation 2.9	Units on a scale
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score	Placebo - Confirmatory Phase	-2.0	Standard Deviation 4.2	Units on a scale
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score	Donepezil 5 mg - Confirmatory Phase	-1.7	Standard Deviation 4.3	Units on a scale
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score	Donepezil 10 mg - Confirmatory Phase	-2.9	Standard Deviation 4.7	Units on a scale

Source ClinicalTrials.gov

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Confirmatory Phase	STARTED	Placebo - Confirmatory Phase	46
Confirmatory Phase	STARTED	Donepezil 5 mg - Confirmatory Phase	47
Confirmatory Phase	STARTED	Donepezil 10 mg - Confirmatory Phase	49
Confirmatory Phase	STARTED	Placebo to Donepezil (5 +10 mg) - Extension Phase	0
Confirmatory Phase	STARTED	Donepezil (5 +10 mg) - Extension Phase	0
Confirmatory Phase	COMPLETED	Placebo - Confirmatory Phase	37
Confirmatory Phase	COMPLETED	Donepezil 5 mg - Confirmatory Phase	31
Confirmatory Phase	COMPLETED	Donepezil 10 mg - Confirmatory Phase	43
Confirmatory Phase	COMPLETED	Placebo to Donepezil (5 +10 mg) - Extension Phase	0
Confirmatory Phase	COMPLETED	Donepezil (5 +10 mg) - Extension Phase	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events295

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Pyrexia	General disorders	Placebo - Confirmatory Phase	0	46
other	Pyrexia	General disorders	Donepezil 5 mg - Confirmatory Phase	0	47
other	Pyrexia	General disorders	Donepezil 10 mg - Confirmatory Phase	3	49
other	Pyrexia	General disorders	Placebo to Donepezil (5 +10 mg) - Extension Phase	0	37
other	Pyrexia	General disorders	Donepezil (5 +10 mg) - Extension Phase	3	96
other	Nasopharyngitis	Infections and infestations	Placebo - Confirmatory Phase	7	46
other	Nasopharyngitis	Infections and infestations	Donepezil 5 mg - Confirmatory Phase	4	47
other	Nasopharyngitis	Infections and infestations	Donepezil 10 mg - Confirmatory Phase	2	49
other	Nasopharyngitis	Infections and infestations	Placebo to Donepezil (5 +10 mg) - Extension Phase	18	37
other	Nasopharyngitis	Infections and infestations	Donepezil (5 +10 mg) - Extension Phase	17	96

1 to 10 of 295Source ClinicalTrials.gov

See all 295 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo - Confirmatory Phase
Total, all-cause mortality	Donepezil 5 mg - Confirmatory Phase
Total, all-cause mortality	Donepezil 10 mg - Confirmatory Phase
Total, all-cause mortality	Placebo to Donepezil (5 +10 mg) - Extension Phase
Total, all-cause mortality	Donepezil (5 +10 mg) - Extension Phase
Total, other adverse events	Placebo - Confirmatory Phase	23	46
Total, other adverse events	Donepezil 5 mg - Confirmatory Phase	18	47
Total, other adverse events	Donepezil 10 mg - Confirmatory Phase	17	49
Total, other adverse events	Placebo to Donepezil (5 +10 mg) - Extension Phase	31	37
Total, other adverse events	Donepezil (5 +10 mg) - Extension Phase	62	96

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25713599	DERIVED	PubMed
25713600	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01278407

GET https://conductscience.org/api/trials/v1/NCT01278407/flow?page=2

API reference For AI assistants