- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278407
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
June 16, 2023 updated by: Eisai Co., Ltd.
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
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Anjo-shi, Aichi, Japan
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Nagoya-shi, Aichi, Japan
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Toyokawa-shi, Aichi, Japan
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Chiba
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Chiba-shi, Chiba, Japan
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Fukui
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Fukui-shi, Fukui, Japan
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Yoshida-gun, Fukui, Japan
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Omuta-shi, Fukuoka, Japan
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Gifu
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Gifu-shi, Gifu, Japan
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Mizunami-shi, Gifu, Japan
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Gunma
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Fujioka-shi, Gunma, Japan
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Maebashi-shi, Gunma, Japan
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Hiroshima
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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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Hokkaido
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Obihiro-shi, Hokkaido, Japan
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Sapporo-shi, Hokkaido, Japan
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Hyogo
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Himeji-shi, Hyogo, Japan
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Kobe-shi, Hyogo, Japan
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Yabu-shi, Hyogo, Japan
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Ibaraki
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Bando-shi, Ibaraki, Japan
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Hitachi-shi, Ibaraki, Japan
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Ishikawa
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Kahoku-shi, Ishikawa, Japan
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Iwate
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Morioka-shi, Iwate, Japan
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Kanagawa
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Fujisawa-shi, Kanagawa, Japan
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Kochi
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Kochi-shi, Kochi, Japan
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Kumamoto
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Koshi-shi, Kumamoto, Japan
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Kumamoto-shi, Kumamoto, Japan
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Kyoto
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Kyoto-shi, Kyoto, Japan
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Uji-shi, Kyoto, Japan
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Miyagi
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Sendai-shi, Miyagi, Japan
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Miyazaki
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Higashimorokata-gun, Miyazaki, Japan
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Nagano
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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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Nagasaki
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Nishisonogi-gun, Nagasaki, Japan
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Niigata
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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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Oita
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Yufu-shi, Oita, Japan
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Osaka
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Osaka-shi, 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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Saitama
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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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Shizuoka
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Fuji-shi, Shizuoka, Japan
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Hamamatsu-shi, Shizuoka, Japan
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Shizuoka-shi, Shizuoka, Japan
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Tokyo
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Koto-ku, Tokyo, Japan
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Ota-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Suginami-ku, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo - Confirmatory Phase
Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
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Experimental: Donepezil 5 mg - 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.
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Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
Other Names:
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Experimental: Donepezil 10 mg - 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.
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Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Names:
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Experimental: Placebo to Donepezil (5 +10 mg) - Extension 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.
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Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Names:
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Experimental: Donepezil (5 +10 mg) - Extension Phase
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.
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Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Mini-Mental State Examination (MMSE) Score
Time Frame: Week 12 for Confirmatory Phase
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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.
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Week 12 for Confirmatory Phase
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Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score
Time Frame: Week 12 for Confirmatory Phase
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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.
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Week 12 for Confirmatory Phase
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Masaki Nakagawa, Neuroscience Clinical Development Section. JAC PCU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
January 14, 2011
First Submitted That Met QC Criteria
January 14, 2011
First Posted (Estimated)
January 17, 2011
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 16, 2023
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dementia
- Lewy Body Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- E2020-J081-341
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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