Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

June 16, 2023 updated by: Eisai Co., Ltd.

Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

351

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

  • Japan
      • Akita, Japan
      • Chiba, Japan
      • Fukuoka, Japan
      • Hiroshima, Japan
      • Iwate, Japan
      • Kagoshima, Japan
      • Kochi, Japan
      • Kyoto, Japan
      • Nara, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Tokushima, Japan
    • Aichi
      • Anjo, Aichi, Japan
      • Obu, Aichi, Japan
      • Toyoake, Aichi, Japan
    • Fukuoka
      • Chikushi, Fukuoka, Japan
      • Kitakyushu, Fukuoka, Japan
    • Gunma
      • Fukuoka, Gunma, Japan
    • Hiroshima
      • Miyoshi, Hiroshima, Japan
      • Otake, Hiroshima, Japan
    • Hyogo
      • Amagasaki, Hyogo, Japan
      • Himeji, Hyogo, Japan
    • Iwate
      • Morioka, Iwate, Japan
    • Kagawa
      • Kida, Kagawa, Japan
      • Takamatsu, Kagawa, Japan
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
      • Sagamihara, Kanagawa, Japan
      • Yokohama, Kanagawa, Japan
      • Yokosuka, Kanagawa, Japan
    • Kyoto
      • Maizuru, Kyoto, Japan
    • Kyushu
      • Nagasaki, Kyushu, Japan
    • Miyagi
      • Sendai, Miyagi, Japan
    • Miyazaki
      • Kitamorokata, Miyazaki, Japan
    • Nagano
      • Ina, Nagano, Japan
    • Niigata
      • Nagaoka, Niigata, Japan
    • Okayama
      • Kurashiki, Okayama, Japan
    • Osaka
      • Ibaraki, Osaka, Japan
      • Ikeda, Osaka, Japan
      • Sakai, Osaka, Japan
      • Sennan, Osaka, Japan
      • Takatsuki, Osaka, Japan
    • Saitama
      • Age, Saitama, Japan
      • Iruma, Saitama, Japan
      • Kasukabe, Saitama, Japan
      • Tokorozawa, Saitama, Japan
    • Shizuoka
      • Fuji, Shizuoka, Japan
      • Izunokuni, Shizuoka, Japan
    • Tokushima
      • Anan, Tokushima, Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
      • Kodaira, Tokyo, Japan
      • Koto, Tokyo, Japan
      • Ota-ku, Tokyo, Japan
      • Setagaya, Tokyo, Japan
      • Suginami, 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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Diagnosis: diagnostic evidence of probable Alzheimer's disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) 290.00 or 290.10
  • Mini Mental State Examination (MMSE) less than or equal to 12 and greater than or equal to1 inclusive, at Screening
  • SIB less than or equal to 90 and greater than or equal to10 at both Screening and Baseline
  • No evidence of focal disease to account for dementia on any cranial image (magnetic resonance imaging [MRI] or computed tomography [CT]).
  • Subject age range: male and female subjects greater than or equal to 50 years of age inclusive
  • Outpatients (patients in nursing homes are eligible)
  • The subject must have a caregiver who will provide informed consent separately for his/her own participation in the study, who will have regular contact with the subject.
  • Stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or equal to 3 months prior to the Screening visit
  • Subjects who can swallow hole tablets, as tablets should not be broken or crushed
  • Comorbid medical conditions must be clinically stable prior to Screening unless otherwise specified.
  • Written informed consent will be obtained from the subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.

Exclusion Criteria

  • Subjects with a known history of disorders that affect cognition or the ability to assess cognition but are distinguishable from AD
  • Subjects with dementia complicated by other organic disease or AD with delirium
  • Known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation
  • Patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary)
  • Use of any prohibited prior or concomitant medications. Memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 mg group
Drug: E2020

Subjects in the Group-10 mg:

Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg

Drug: E2020

Subjects in the Group-23 mg:

Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg
Active Comparator: 23 mg group
Drug: E2020

Subjects in the Group-10 mg:

Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg

Drug: E2020

Subjects in the Group-23 mg:

Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Severe Impairment Battery (SIB)
Time Frame: 24 weeks
SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
24 weeks
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)
Time Frame: 24 weeks
CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)
24 weeks

Collaborators and Investigators

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

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Naoki Kubota, Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.

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

March 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimated)

February 27, 2012

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020-J081-343

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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