Trial · NCT00478205

Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease

NCT00478205, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease. Trials, record NCT00478205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478205

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Trial

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

Title: Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
NCT number: NCT00478205
Status: Completed
Phases: Phase 3
Enrollment: 1,467 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Alzheimer's Disease
Interventions: Aricept (donepezil SR 23 mg), Aricept (donepezil IR 10 mg)
First posted: 2007-05-24
Last updated: 2014-07-11
Other registries' IDs: eudract:2006-004888-54
Results first posted: 2013-02-05

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 24 in SIB Total Score	Baseline and Week 24	The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.
Primary	Overall Change From Baseline in Modified CIBIC+ to Week 24	Baseline and Week 24	The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).
Secondary	Change From Baseline to Week 24 in ADCS-ADL Total Score	Baseline and Week 24	The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability.
Secondary	Change From Baseline to Week 24 in MMSE Total Score	Baseline and Week 24	The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).

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	Change From Baseline to Week 24 in SIB Total Score	Baseline and Week 24	Intent-to-treat (ITT) population: All Randomized patients in Safety Population and Severe Impairment Battery (SIB) or Clinician Interview-Based Impression of Severity Plus Caregiver Input (CIBIS+) data available at Baseline and SIB or Clinician Interview-Based Impression of Change Plus caregiver Input (CIBIC+ ) data available post-Baseline; LOCF	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 24 in ADCS-ADL Total Score	Baseline and Week 24	ITT population, LOCF	Scores on a scale	MEAN
SECONDARY	Change From Baseline to Week 24 in MMSE Total Score	Baseline and Week 24	ITT population, LOCF	Scores on a scale	MEAN
PRIMARY	Overall Change From Baseline in Modified CIBIC+ to Week 24	Baseline and Week 24	ITT population, LOCF	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 24 in SIB Total Score	Donepezil SR 23 mg	2.6	Standard Error 0.58	Scores on a scale
Change From Baseline to Week 24 in SIB Total Score	Donepezil IR 10 mg	0.4	Standard Error 0.66	Scores on a scale
Change From Baseline to Week 24 in ADCS-ADL Total Score	Donepezil SR 23 mg	-1.2	Standard Deviation 6.83	Scores on a scale
Change From Baseline to Week 24 in ADCS-ADL Total Score	Donepezil IR 10 mg	-1.2	Standard Deviation 6.78	Scores on a scale
Change From Baseline to Week 24 in MMSE Total Score	Donepezil SR 23 mg	0.6	Standard Deviation 2.93	Scores on a scale
Change From Baseline to Week 24 in MMSE Total Score	Donepezil IR 10 mg	0.4	Standard Deviation 3.20	Scores on a scale
Overall Change From Baseline in Modified CIBIC+ to Week 24	Donepezil SR 23 mg	4.23	Standard Deviation 1.07	Scores on a scale
Overall Change From Baseline in Modified CIBIC+ to Week 24	Donepezil IR 10 mg	4.29	Standard Deviation 1.07	Scores on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Donepezil SR 23 mg	981
Overall Study	STARTED	Donepezil IR 10 mg	486
Overall Study	COMPLETED	Donepezil SR 23 mg	685
Overall Study	COMPLETED	Donepezil IR 10 mg	399
Overall Study	NOT COMPLETED	Donepezil SR 23 mg	296
Overall Study	NOT COMPLETED	Donepezil IR 10 mg	87

Source ClinicalTrials.gov

Adverse events260

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	Diarrhoea	Gastrointestinal disorders	Donepezil SR 23 mg	76	963
other	Diarrhoea	Gastrointestinal disorders	Donepezil IR 10 mg	25	471
other	Nausea	Gastrointestinal disorders	Donepezil SR 23 mg	113	963
other	Nausea	Gastrointestinal disorders	Donepezil IR 10 mg	16	471
other	Vomiting	Gastrointestinal disorders	Donepezil SR 23 mg	86	963
other	Vomiting	Gastrointestinal disorders	Donepezil IR 10 mg	12	471
other	Anorexia	Metabolism and nutrition disorders	Donepezil SR 23 mg	51	963
other	Anorexia	Metabolism and nutrition disorders	Donepezil IR 10 mg	8	471
serious	Anaemia	Blood and lymphatic system disorders	Donepezil SR 23 mg	1	963
serious	Anaemia	Blood and lymphatic system disorders	Donepezil IR 10 mg	0	471

1 to 10 of 260Source ClinicalTrials.gov

See all 260 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Donepezil SR 23 mg
Total, all-cause mortality	Donepezil IR 10 mg
Total, other adverse events	Donepezil SR 23 mg	233	963
Total, other adverse events	Donepezil IR 10 mg	50	471
Total, serious adverse events	Donepezil SR 23 mg	80	963
Total, serious adverse events	Donepezil IR 10 mg	45	471

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20678673	DERIVED	PubMed
21612646	DERIVED	PubMed
21689411	DERIVED	PubMed
22572767	DERIVED	PubMed
22930699	DERIVED	PubMed
24073978	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 comparisons1

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

Comparison
Donepezil SR 23 mg vs Donepezil IR 10 mg: serious adverse events

Source Trial comparisons

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/NCT00478205

GET https://conductscience.org/api/trials/v1/NCT00478205/events?page=2

API reference For AI assistants