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.
ClinicalTrials.gov Identifier:
NCT01276353
First received: January 12, 2011
Last updated: August 5, 2014
Last verified: August 2014

January 12, 2011
August 5, 2014
January 2011
April 2012   (final data collection date for primary outcome measure)
Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3 [ Time Frame: Visit 2 [Day1] and Visit 3 [Day 15] ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01276353 on ClinicalTrials.gov Archive Site
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status [ Time Frame: Visit 2 [Day1] and Visit 3 [Day 15] ] [ Designated as safety issue: No ]
All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i
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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

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Type Dementia
  • 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.
  • Experimental: 1
    Intervention: Drug: E2020
  • Active Comparator: 2
    Intervention: Drug: E2020
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01276353
E2020-J081-221
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Naoki Kubota Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Eisai Inc.
August 2014

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