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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc. ( Eisai Co., Ltd. )

ClinicalTrials.gov Identifier:

NCT00543855

First received: October 4, 2007

Last updated: March 5, 2013

Last verified: March 2013

History of Changes

Results First Received: January 16, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Dementia With Lewy Bodies (DLB)
Interventions:	Drug: 3 mg Donepezil hydrochloride Drug: 5 mg Donepezil hydrochloride Drug: 10 mg Donepezil hydrochloride Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
167 participants initiated the Observation period, 140 participants were enrolled in the treatment period, one participant did not receive treatment.

Reporting Groups

	Description
3 mg Donepezil Hydrochloride	E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
5 mg Donepezil Hydrochloride	E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
10 mg Donepezil Hydrochloride	E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).
Placebo	Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Participant Flow: Overall Study

	3 mg Donepezil Hydrochloride	5 mg Donepezil Hydrochloride	10 mg Donepezil Hydrochloride	Placebo
STARTED	35	33	37	34
COMPLETED	31	31	31	30
NOT COMPLETED	4	2	6	4
Adverse Event	3	1	3	4
Lost to Follow-up	0	0	1	0
Withdrawal by Subject	0	1	2	0
Protocol Violation	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
3 mg Donepezil Hydrochloride	E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
5 mg Donepezil Hydrochloride	E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
10 mg Donepezil Hydrochloride	E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
Placebo	Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
Total	Total of all reporting groups

Baseline Measures

	3 mg Donepezil Hydrochloride	5 mg Donepezil Hydrochloride	10 mg Donepezil Hydrochloride	Placebo	Total
Number of Participants [units: participants]	35	33	37	34	139
Age [units: years] Mean ± Standard Deviation	79.6 ± 4.5	77.9 ± 6.7	78.4 ± 6.1	78.7 ± 4.9	78.7 ± 5.6
Gender [units: participants]
Female	18	16	33	23	90
Male	17	17	4	11	49

Outcome Measures

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1. Primary:

Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and every 4 weeks up to 12 weeks ]

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2. Primary:

Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and every 4 weeks up to 12 weeks ]

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3. 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) [ Time Frame: Baseline and week 12 ]

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4. Primary:

Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Masaki Nakagawa, Study Director
Organization: Eisai Co., Ltd.
phone: +81-3-3817-5245

No publications provided

Responsible Party:	Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:	NCT00543855 History of Changes
Other Study ID Numbers:	E2020-J081-431
Study First Received:	October 4, 2007
Results First Received:	January 16, 2013
Last Updated:	March 5, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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