Clinical trial NCT01276353: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Type Dementia
Keywords: Alzheimer Disease
Dementia
Delirium
Amnestic
Cognitive Disorders
Donepezil
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cholinesterase Inhibitors
Enzy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* 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

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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
timeFrame: Visit 2 [Day1] and Visit 3 [Day 15]
Secondary outcomes:
measure: Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
timeFrame: Visit 2 [Day1] and Visit 3 [Day 15]
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
state: Fukuoka
city: Mizunami
country: Japan
state: Gifu
city: Yokosuka
country: Japan
state: Kanagawa
city: Sanjo
country: Japan
state: Niigata
city: Kurashiki
country: Japan
state: Okayama
city: Fuji
country: Japan
state: Shizuoka
city: Hachioji
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Fukuoka
country: Japan
city: Saitama
country: Japan
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Naoki Kubota
role: STUDY_DIRECTOR
References: