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Dementia With Lewy Bodies (DLB)Phase 3NCT01278407

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

A Phase 3 study testing Donepezil 5 mg and Donepezil 10 mg in people with Dementia With Lewy Bodies (DLB), run by Eisai Co., Ltd. at 56 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Dementia With Lewy Bodies (DLB)
What is being tested?
Donepezil 5 mg and Donepezil 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
56 sitesJapan
Study dates
Feb 2011to Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

Japan56 sites

  • Study site

    Ageo-shi, Saitama

  • Study site

    Anjo-shi, Aichi-ken

  • Study site

    Bando-shi, Ibaraki

  • Study site

    Chiba, Chiba

  • Study site

    Fuji-shi, Shizuoka

  • Study site

    Fujioka-shi, Gunma

  • Study site

    Fujisawa-shi, Kanagawa

  • Study site

    Fukui-shi, Fukui

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Gifu, Gifu

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Higashimorokata-gun, Miyazaki

  • Study site

    Himeji-shi, Hyōgo

  • Study site

    Hitachi-shi, Ibaraki

  • Study site

    Ina-shi, Nagano

  • Study site

    Kahoku, Ishikawa-ken

  • Study site

    Kasukabe-shi, Saitama

  • Study site

    Kitaazumi-gun, Nagano

  • Study site

    Kitakyushu-shi, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi, Kochi

  • Study site

    Koshi-shi, Kumamoto

  • Study site

    Koto-ku, Tokyo

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kure-shi, Hiroshima

  • Study site

    Kyoto, Kyoto

  • Study site

    Maebashi, Gunma

  • Study site

    Matsumoto-shi, Nagano

  • Study site

    Miyoshi-shi, Hiroshima

  • Study site

    Mizunami-shi, Gifu

  • Study site

    Morioka, Iwate

  • Study site

    Nagaoka-shi, Niigata

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nishisonogi-gun, Nagasaki

  • Study site

    Obihiro-shi, Hokkaido

  • Study site

    Omuta-shi, Fukuoka

  • Study site

    Osaka, Osaka

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Otake-shi, Hiroshima

  • Study site

    Saitama-shi, Saitama

  • Study site

    Sakai-shi, Osaka

  • Study site

    Sanjo-shi, Niigata

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Sennan-shi, Osaka

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Suginami-ku, Tokyo

  • Study site

    Suita-shi, Osaka

  • Study site

    Toyokawa-shi, Aichi-ken

  • Study site

    Tsubame-shi, Niigata

  • Study site

    Uji-shi, Kyoto

  • Study site

    Yabu-shi, Hyōgo

  • Study site

    Yoshida-gun, Fukui

  • Study site

    Yufu-shi, Oita Prefecture

Other trials in Japan

About this study

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

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Read the 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.

Being tested
Donepezil 5 mg, Donepezil 10 mg, Donepezil matched placebo
Keywords
DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept
Medical subject headings
Lewy Body Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donepezil 5 mgDrug

    Also called E2020

    Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg

  • Donepezil 10 mgDrug

    Also called E2020

    Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg

  • Donepezil matched placeboDrug

Study groups in NCT01278407
Study groupRoleWhat they receive
Placebo - Confirmatory PhasePlacebo comparatorParticipants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
Receives: Drug: Donepezil matched placebo
Donepezil 5 mg - Confirmatory PhaseExperimentalParticipants 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.
Receives: Drug: Donepezil 5 mg
Donepezil 10 mg - Confirmatory PhaseExperimentalParticipants 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.
Receives: Drug: Donepezil 10 mg
Placebo to Donepezil (5 +10 mg) - Extension PhaseExperimentalParticipants 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.
Receives: Drug: Donepezil 10 mg
Donepezil (5 +10 mg) - Extension PhaseExperimentalParticipants 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.
Receives: Drug: Donepezil 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12 for Confirmatory Phase

  2. 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.

    Measured: Week 12 for Confirmatory Phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01278407
Sponsor's protocol ID
E2020-J081-341
Status last verified
Dec 2015
First submitted
14 Jan 2011
Last updated
29 Jun 2023

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.

    PubMed 25713600

  • 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.

    PubMed 25713599

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Donepezil 5 mg and Donepezil 10 mg in people with Dementia With Lewy Bodies (DLB), run by Eisai Co., Ltd. at 56 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mini-Mental State Examination (MMSE) Score (time frame: Week 12 for Confirmatory Phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01278407, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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