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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Japan
    • Aichi
      • Anjo-shi, Aichi, Japan
      • Nagoya-shi, Aichi, Japan
      • Toyokawa-shi, Aichi, Japan
    • Chiba
      • Chiba-shi, Chiba, Japan
    • Fukui
      • Fukui-shi, Fukui, Japan
      • Yoshida-gun, Fukui, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Kitakyushu-shi, Fukuoka, Japan
      • Omuta-shi, Fukuoka, Japan
    • Gifu
      • Gifu-shi, Gifu, Japan
      • Mizunami-shi, Gifu, Japan
    • Gunma
      • Fujioka-shi, Gunma, Japan
      • Maebashi-shi, Gunma, Japan
    • Hiroshima
      • Kure-shi, Hiroshima, Japan
      • Miyoshi-shi, Hiroshima, Japan
      • Otake-shi, Hiroshima, Japan
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Hyogo
      • Himeji-shi, Hyogo, Japan
      • Kobe-shi, Hyogo, Japan
      • Yabu-shi, Hyogo, Japan
    • Ibaraki
      • Bando-shi, Ibaraki, Japan
      • Hitachi-shi, Ibaraki, Japan
    • Ishikawa
      • Kahoku-shi, Ishikawa, Japan
    • Iwate
      • Morioka-shi, Iwate, Japan
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan
    • Kochi
      • Kochi-shi, Kochi, Japan
    • Kumamoto
      • Koshi-shi, Kumamoto, Japan
      • Kumamoto-shi, Kumamoto, Japan
    • Kyoto
      • Kyoto-shi, Kyoto, Japan
      • Uji-shi, Kyoto, Japan
    • Miyagi
      • Sendai-shi, Miyagi, Japan
    • Miyazaki
      • Higashimorokata-gun, Miyazaki, Japan
    • Nagano
      • Ina-shi, Nagano, Japan
      • Kitaazumi-gun, Nagano, Japan
      • Matsumoto-shi, Nagano, Japan
    • Nagasaki
      • Nishisonogi-gun, Nagasaki, Japan
    • Niigata
      • Nagaoka-shi, Niigata, Japan
      • Sanjo-shi, Niigata, Japan
      • Tsubame-shi, Niigata, Japan
    • Oita
      • Yufu-shi, Oita, Japan
    • Osaka
      • Osaka-shi, Osaka, Japan
      • Sakai-shi, Osaka, Japan
      • Sennan-shi, Osaka, Japan
      • Suita-shi, Osaka, Japan
    • Saitama
      • Ageo-shi, Saitama, Japan
      • Kasukabe-shi, Saitama, Japan
      • Saitama-shi, Saitama, Japan
    • Shizuoka
      • Fuji-shi, Shizuoka, Japan
      • Hamamatsu-shi, Shizuoka, Japan
      • Shizuoka-shi, Shizuoka, Japan
    • Tokyo
      • Koto-ku, Tokyo, Japan
      • Ota-ku, Tokyo, Japan
      • Setagaya-ku, Tokyo, Japan
      • Shinjuku-ku, Tokyo, Japan
      • Suginami-ku, Tokyo, Japan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo - Confirmatory Phase
Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
Drug: Donepezil matched placebo
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.
Drug: Donepezil 5 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
Other Names:
  • E2020
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.
Drug: Donepezil 10 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Names:
  • E2020
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.
Drug: Donepezil 10 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Names:
  • E2020
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.
Drug: Donepezil 10 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Names:
  • E2020

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mini-Mental State Examination (MMSE) Score
Time Frame: Week 12 for Confirmatory Phase
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
Time Frame: Week 12 for Confirmatory Phase
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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