A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc. ( Eisai Co., Ltd. )

ClinicalTrials.gov Identifier:

NCT01276353

First received: January 12, 2011

Last updated: December 27, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2011

Last Updated Date

December 27, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To explore the safety and the tolerability of E2020 SR 23 mg: number of subjects with AEs will be measured. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01276353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Official Title ^ICMJE

A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Type Dementia

Intervention ^ICMJE

Drug: E2020
Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation
Drug: E2020
10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.

Study Arm (s)

Experimental: 1
Intervention: Drug: E2020
Active Comparator: 2
Intervention: Drug: E2020

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

Diagnostic evidence of probable Alzheimer's disease (AD) consistent with the Diagnostic and Statistical Manual for Mental Disorders-version IV (DSM-IV).
Hachinski Ischemic Score ≤ 6.
Functional Assessment Staging (FAST) scale ≥ 6 at Screening.
Mini-Mental State Examination (MMSE) score of 1 to 12 at Screening
Subjects who are on a stable Aricept® dose of 10 mg immediate release (IR), taken as a single, daily dose for ≥ 3 months prior to the Screening Visit.
Evidence consistent with Alzheimer's disease (AD) on any cranial image on magnetic resonance imaging (MRI) or computed tomography (CT) scan or etc. obtained within 24 months prior to the Screening Visit. Subjects who have any observations of dementia other than Alzheimer's type after the last image diagnosis should be reconfirmed.
Age ≥ 50 years
Written informed consent is to have been obtained from the subject (if possible) or from the subject's legal guardian or other representative

Exclusion Criteria

Subjects with dementia other than Alzheimer's type.
Subjects with significant neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, a history of head injury with loss of consciousness, or a history of brain surgery followed by persistent deficits.
Subjects with allergy to donepezil hydrochloride or piperidine derivatives.
Subjects with a cause of Alzheimer's disease (AD) which is supported by any laboratory tests such as Vitamin B12, folate levels, triiodothyronine, free triiodothyronine, thyroxine, thyroid stimulating hormone (TSH) or serologic test for syphilis

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01276353

Other Study ID Numbers ^ICMJE

E2020-J081-221

Has Data Monitoring Committee

Not Provided

Responsible Party

Eisai Inc. ( Eisai Co., Ltd. )

Study Sponsor ^ICMJE

Eisai Co., Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Naoki Kubota

Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Information Provided By

Eisai Inc.

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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