Brief Summary

The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

260

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2011

Typical duration for phase_3

Geographic Reach

1 country

32 active sites

Status

completed

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

3 years study duration

First Submitted

Initial submission to the registry

July 26, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed

1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

July 26, 2011

Last Update Submit

March 7, 2017

Conditions

Alzheimer's Type Dementia

Keywords

Alzheimer DiseaseDementiaDeliriumAmnesticCognitive DisordersDonepezilBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesMental DisordersCholinesterase InhibitorsEnzy

Outcome Measures

Primary Outcomes (1)

The change in the total Severe Impairment Battery (SIB) score at Week 24
All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.
24 weeks

Secondary Outcomes (1)

Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
24 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: E2020

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E2020DRUG

In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.

PlaceboDRUG

Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

Eligibility Criteria

Age50 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
Subject age range: male and female subjects 50 to 90 years of age, inclusive
Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
MMSE 1 to 12 inclusive, at both Screening and Baseline
SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

You may not qualify if:

Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
Evidence of focal disease to account for dementia on any cranial image MRI or CT.
Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
Illiteracy prior to AD
Subjects who are unwilling or unable to fulfill the requirements of the study
Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
Subjects with a poor response (tolerability) to prior exposure to donepezil

Contact the study team to confirm eligibility.