A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
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
1 other identifier
interventional
142
1 country
56
Brief Summary
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2011
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
November 30, 2015
CompletedJune 29, 2023
December 1, 2015
2.1 years
January 14, 2011
October 27, 2015
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Week 12 for Confirmatory Phase
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.
Week 12 for Confirmatory Phase
Study Arms (5)
Placebo - Confirmatory Phase
PLACEBO COMPARATORParticipants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
Donepezil 5 mg - Confirmatory Phase
EXPERIMENTALParticipants 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.
Donepezil 10 mg - Confirmatory Phase
EXPERIMENTALParticipants 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.
Placebo to Donepezil (5 +10 mg) - Extension Phase
EXPERIMENTALParticipants 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.
Donepezil (5 +10 mg) - Extension Phase
EXPERIMENTALParticipants 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.
Interventions
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (56)
Unknown Facility
Anjo-shi, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Toyokawa-shi, Aichi-ken, Japan
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Chiba, Chiba, Japan
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Fukui-shi, Fukui, Japan
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Yoshida-gun, Fukui, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Omuta-shi, Fukuoka, Japan
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Gifu, Gifu, Japan
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Mizunami-shi, Gifu, Japan
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Fujioka-shi, Gunma, Japan
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Maebashi, Gunma, Japan
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Kure-shi, Hiroshima, Japan
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Miyoshi-shi, Hiroshima, Japan
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Otake-shi, Hiroshima, Japan
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Obihiro-shi, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Himeji-shi, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Yabu-shi, Hyōgo, Japan
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Bando-shi, Ibaraki, Japan
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Hitachi-shi, Ibaraki, Japan
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Kahoku, Ishikawa-ken, Japan
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Morioka, Iwate, Japan
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Fujisawa-shi, Kanagawa, Japan
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Kochi, Kochi, Japan
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Koshi-shi, Kumamoto, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Uji-shi, Kyoto, Japan
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Sendai, Miyagi, Japan
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Higashimorokata-gun, Miyazaki, Japan
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Ina-shi, Nagano, Japan
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Kitaazumi-gun, Nagano, Japan
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Matsumoto-shi, Nagano, Japan
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Nishisonogi-gun, Nagasaki, Japan
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Nagaoka-shi, Niigata, Japan
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Sanjo-shi, Niigata, Japan
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Tsubame-shi, Niigata, Japan
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Yufu-shi, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Sennan-shi, Osaka, Japan
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Suita-shi, Osaka, Japan
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Ageo-shi, Saitama, Japan
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Kasukabe-shi, Saitama, Japan
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Saitama-shi, Saitama, Japan
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Fuji-shi, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Shizuoka, Shizuoka, Japan
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Koto-ku, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
Unknown Facility
Shinjuku-ku, Tokyo, Japan
Unknown Facility
Suginami-ku, Tokyo, Japan
Related Publications (2)
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.
PMID: 25713600DERIVEDIkeda 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.
PMID: 25713599DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Masaki Nakagawa
- Organization
- Eisai Co., Ltd.
Study Officials
- STUDY DIRECTOR
Masaki Nakagawa
Neuroscience Clinical Development Section. JAC PCU
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 17, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
June 29, 2023
Results First Posted
November 30, 2015
Record last verified: 2015-12