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
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
1 other identifier
interventional
45
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 12, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
August 1, 2014
CompletedAugust 8, 2014
August 1, 2014
1.2 years
January 12, 2011
February 24, 2014
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
Visit 2 [Day1] and Visit 3 [Day 15]
Secondary Outcomes (1)
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Visit 2 [Day1] and Visit 3 [Day 15]
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
- Functional Assessment Staging (FAST) scale greater than or equal to 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (11)
Unknown Facility
Akita, Akita, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kitakyushu, Fukuoka, Japan
Unknown Facility
Mizunami, Gifu, Japan
Unknown Facility
Yokosuka, Kanagawa, Japan
Unknown Facility
Sanjō, Niigata, Japan
Unknown Facility
Kurashiki, Okayama-ken, Japan
Unknown Facility
Saitama, Saitama, Japan
Unknown Facility
Fuji, Shizuoka, Japan
Unknown Facility
Hachiōji, Tokyo, Japan
Unknown Facility
Kodaira, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naoki Kubota
- Organization
- Clinical Development. JAC PCU. Eisai Co., Ltd.
Study Officials
- STUDY DIRECTOR
Naoki Kubota
Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2011
First Posted
January 13, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
August 8, 2014
Results First Posted
August 1, 2014
Record last verified: 2014-08