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

Primary Purpose

Dementia With Lewy Bodies (DLB)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Donepezil 5 mg
Donepezil 10 mg
Donepezil matched placebo
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia With Lewy Bodies (DLB) focused on measuring DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
  2. Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
  3. Clinical Dementia Rating (CDR) score ≥ 0.5
  4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

  1. Patients diagnosed with Parkinson's disease with dementia (PDD)
  2. Patients who received anti-dementia drug therapy at the same institution
  3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
  4. 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, or a history of brain surgery causing unrecovered deficiency
  5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
  6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo - Confirmatory Phase

Donepezil 5 mg - Confirmatory Phase

Donepezil 10 mg - Confirmatory Phase

Placebo to Donepezil (5 +10 mg) - Extension Phase

Donepezil (5 +10 mg) - Extension Phase

Arm Description

Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.

Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.

Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.

Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.

Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.

Outcomes

Primary Outcome Measures

Change From Baseline in Mini-Mental State Examination (MMSE) Score
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.
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score
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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2011
Last Updated
June 16, 2023
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01278407
Brief Title
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
Official Title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).
Detailed Description
This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies (DLB)
Keywords
DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo - Confirmatory Phase
Arm Type
Placebo Comparator
Arm Description
Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
Arm Title
Donepezil 5 mg - Confirmatory Phase
Arm Type
Experimental
Arm Description
Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
Arm Title
Donepezil 10 mg - Confirmatory Phase
Arm Type
Experimental
Arm Description
Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
Arm Title
Placebo to Donepezil (5 +10 mg) - Extension Phase
Arm Type
Experimental
Arm Description
Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Arm Title
Donepezil (5 +10 mg) - Extension Phase
Arm Type
Experimental
Arm Description
Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Intervention Type
Drug
Intervention Name(s)
Donepezil 5 mg
Other Intervention Name(s)
E2020
Intervention Description
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
Intervention Type
Drug
Intervention Name(s)
Donepezil 10 mg
Other Intervention Name(s)
E2020
Intervention Description
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Intervention Type
Drug
Intervention Name(s)
Donepezil matched placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Mini-Mental State Examination (MMSE) Score
Description
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.
Time Frame
Week 12 for Confirmatory Phase
Title
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score
Description
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.
Time Frame
Week 12 for Confirmatory Phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution Clinical Dementia Rating (CDR) score ≥ 0.5 Mini-Mental State Examination (MMSE) score of 10 to 26 Exclusion Criteria Patients diagnosed with Parkinson's disease with dementia (PDD) Patients who received anti-dementia drug therapy at the same institution Patients who received anti-dementia drug therapy within 12 weeks before start of Screening 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, or a history of brain surgery causing unrecovered deficiency Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV) Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaki Nakagawa
Organizational Affiliation
Neuroscience Clinical Development Section. JAC PCU
Official's Role
Study Director
Facility Information:
City
Anjo-shi
State/Province
Aichi
Country
Japan
City
Nagoya-shi
State/Province
Aichi
Country
Japan
City
Toyokawa-shi
State/Province
Aichi
Country
Japan
City
Chiba-shi
State/Province
Chiba
Country
Japan
City
Fukui-shi
State/Province
Fukui
Country
Japan
City
Yoshida-gun
State/Province
Fukui
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
City
Omuta-shi
State/Province
Fukuoka
Country
Japan
City
Gifu-shi
State/Province
Gifu
Country
Japan
City
Mizunami-shi
State/Province
Gifu
Country
Japan
City
Fujioka-shi
State/Province
Gunma
Country
Japan
City
Maebashi-shi
State/Province
Gunma
Country
Japan
City
Kure-shi
State/Province
Hiroshima
Country
Japan
City
Miyoshi-shi
State/Province
Hiroshima
Country
Japan
City
Otake-shi
State/Province
Hiroshima
Country
Japan
City
Obihiro-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Himeji-shi
State/Province
Hyogo
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan
City
Yabu-shi
State/Province
Hyogo
Country
Japan
City
Bando-shi
State/Province
Ibaraki
Country
Japan
City
Hitachi-shi
State/Province
Ibaraki
Country
Japan
City
Kahoku-shi
State/Province
Ishikawa
Country
Japan
City
Morioka-shi
State/Province
Iwate
Country
Japan
City
Fujisawa-shi
State/Province
Kanagawa
Country
Japan
City
Kochi-shi
State/Province
Kochi
Country
Japan
City
Koshi-shi
State/Province
Kumamoto
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Uji-shi
State/Province
Kyoto
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Higashimorokata-gun
State/Province
Miyazaki
Country
Japan
City
Ina-shi
State/Province
Nagano
Country
Japan
City
Kitaazumi-gun
State/Province
Nagano
Country
Japan
City
Matsumoto-shi
State/Province
Nagano
Country
Japan
City
Nishisonogi-gun
State/Province
Nagasaki
Country
Japan
City
Nagaoka-shi
State/Province
Niigata
Country
Japan
City
Sanjo-shi
State/Province
Niigata
Country
Japan
City
Tsubame-shi
State/Province
Niigata
Country
Japan
City
Yufu-shi
State/Province
Oita
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Sakai-shi
State/Province
Osaka
Country
Japan
City
Sennan-shi
State/Province
Osaka
Country
Japan
City
Suita-shi
State/Province
Osaka
Country
Japan
City
Ageo-shi
State/Province
Saitama
Country
Japan
City
Kasukabe-shi
State/Province
Saitama
Country
Japan
City
Saitama-shi
State/Province
Saitama
Country
Japan
City
Fuji-shi
State/Province
Shizuoka
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Suginami-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25713600
Citation
Mori E, Ikeda M, Nagai R, Matsuo K, Nakagawa M, Kosaka K. Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):5. doi: 10.1186/s13195-014-0081-2. eCollection 2015.
Results Reference
derived
PubMed Identifier
25713599
Citation
Ikeda M, Mori E, Matsuo K, Nakagawa M, Kosaka K. Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):4. doi: 10.1186/s13195-014-0083-0. eCollection 2015.
Results Reference
derived

Learn more about this trial

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

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