Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease

Part of paid clinical trials in Hickory, North Carolina.

Sponsor
Eisai Inc.
Study ID
NCT00478205
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Aricept (donepezil SR 23 mg) — DRUG
    Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation.
  • Aricept (donepezil IR 10 mg) — DRUG
    Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation.

Study Details

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 moderate to severe Alzheimer's disease.

Key Dates

Start date
Jun 30, 2007
Status verified
Jan 2013
Primary completion
Jun 30, 2009

Study Design

Enrollment
1,467 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Change From Baseline to Week 24 in SIB Total Score [ Time Frame: Baseline and Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
MedTrials, Inc.HickoryNorth Carolina28601-

Find similar trials in Hickory, NC

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
MedTrials, Inc.· Hickory, NC

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