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Clinical Trial Details

Overview

Research Study Summary

A Phase 3 clinical study for patients with Alzheimer's Type Dementia

Research Study Title

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

Purpose

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.

To Learn more
Phase

3

Gender

Both Male and Female

Age

50 and up

Overall Status

Recruiting

Lead Sponsor

Eisai Co., Ltd.

Duration

36 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years and up

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.

Site Locations (54)

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

Contact

Customer Joy Department. EJ

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01539031

Date Last Changed: February 13, 2014

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