Trial · NCT00543855

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

NCT00543855, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2013-02-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431). Trials, record NCT00543855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00543855

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Trial

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

Title: A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
NCT number: NCT00543855
Status: Completed
Phases: Phase 2
Enrollment: 167 participants, actual
Lead sponsor: Eisai Co., Ltd.
Conditions: Dementia With Lewy Bodies (DLB)
Interventions: 3 mg Donepezil hydrochloride, 5 mg Donepezil hydrochloride, 10 mg Donepezil hydrochloride, Placebo
First posted: 2007-10-15
Last updated: 2013-03-08
Results first posted: 2013-02-18

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and every 4 weeks up to 12 weeks	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: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Primary	Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and every 4 weeks up to 12 weeks	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." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Primary	Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and week 12	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". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Primary	Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and Week 12	J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia. ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and every 4 weeks up to 12 weeks	Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.	Score on a scale	MEAN
PRIMARY	Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and every 4 weeks up to 12 weeks	Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.	Score on a scale	MEAN
PRIMARY	Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and week 12	Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.	Percentage of Participants	NUMBER
PRIMARY	Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and Week 12	Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.	Score on a scale	MEAN

Source ClinicalTrials.gov

Results by group52

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

Outcome	Group	Category	Value	Spread	Units
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	3 mg Donepezil Hydrochloride	Baseline	20.1	Standard Deviation 4.2	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	5 mg Donepezil Hydrochloride	Baseline	19.7	Standard Deviation 4.4	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	10 mg Donepezil Hydrochloride	Baseline	19.7	Standard Deviation 4.5	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	Placebo	Baseline	18.2	Standard Deviation 4.8	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	3 mg Donepezil Hydrochloride	Change from Baseline (LOCF)	1.2	Standard Deviation 3.8	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	5 mg Donepezil Hydrochloride	Change from Baseline (LOCF)	3.5	Standard Deviation 3.2	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	10 mg Donepezil Hydrochloride	Change from Baseline (LOCF)	2.3	Standard Deviation 3.2	Score on a scale
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	Placebo	Change from Baseline (LOCF)	-0.6	Standard Deviation 2.7	Score on a scale
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)	3 mg Donepezil Hydrochloride	Baseline	20.9	Standard Deviation 13.1	Score on a scale
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)	5 mg Donepezil Hydrochloride	Baseline	14.2	Standard Deviation 8.4	Score on a scale

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	3 mg Donepezil Hydrochloride	35
Overall Study	STARTED	5 mg Donepezil Hydrochloride	33
Overall Study	STARTED	10 mg Donepezil Hydrochloride	37
Overall Study	STARTED	Placebo	34
Overall Study	COMPLETED	3 mg Donepezil Hydrochloride	31
Overall Study	COMPLETED	5 mg Donepezil Hydrochloride	31
Overall Study	COMPLETED	10 mg Donepezil Hydrochloride	31
Overall Study	COMPLETED	Placebo	30
Overall Study	NOT COMPLETED	3 mg Donepezil Hydrochloride	4
Overall Study	NOT COMPLETED	5 mg Donepezil Hydrochloride	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events148

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	Nasopharyngitis	Infections and infestations	3 mg Donepezil Hydrochloride	3	35
other	Nasopharyngitis	Infections and infestations	5 mg Donepezil Hydrochloride	2	33
other	Nasopharyngitis	Infections and infestations	10 mg Donepezil Hydrochloride	4	37
other	Nasopharyngitis	Infections and infestations	Placebo	1	34
other	Gastroenteritis	Infections and infestations	3 mg Donepezil Hydrochloride	0	35
other	Gastroenteritis	Infections and infestations	5 mg Donepezil Hydrochloride	0	33
other	Gastroenteritis	Infections and infestations	10 mg Donepezil Hydrochloride	3	37
other	Gastroenteritis	Infections and infestations	Placebo	0	34
other	Diabetes Mellitus	Metabolism and nutrition disorders	3 mg Donepezil Hydrochloride	0	35
other	Diabetes Mellitus	Metabolism and nutrition disorders	5 mg Donepezil Hydrochloride	2	33

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	3 mg Donepezil Hydrochloride
Total, all-cause mortality	5 mg Donepezil Hydrochloride
Total, all-cause mortality	10 mg Donepezil Hydrochloride
Total, all-cause mortality	Placebo
Total, other adverse events	3 mg Donepezil Hydrochloride	24	35
Total, other adverse events	5 mg Donepezil Hydrochloride	27	33
Total, other adverse events	10 mg Donepezil Hydrochloride	32	37
Total, other adverse events	Placebo	24	34
Total, serious adverse events	3 mg Donepezil Hydrochloride	2	35
Total, serious adverse events	5 mg Donepezil Hydrochloride	2	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT00543855

GET https://conductscience.org/api/trials/v1/NCT00543855/results?page=2

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