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
Condition: Alzheimer's Type Dementia
MeSH terms: Dementia; Alzheimer Disease
Intervention: E2020; E2020
Intervention description: 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; 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.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
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

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