The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Eisai

Status and phase: Completed; Phase 4

Conditions: Memory Loss

Treatments: Drug: Placebo; Drug: Donepezil Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293176

E2020-A001-412

Details and patient eligibility

About

To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.

Enrollment: 821 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Memory complaint
• Mini Mental Status Exam (MMSE) score 24-28 inclusive
• General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
• Generally healthy and ambulatory
• Sufficiently fluent in English

Exclusion criteria

• Diagnosis of probable or possible AD
• Neurological disorders
• History of malignant cancers
• Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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821 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Donepezil Hydrochloride

2

Placebo Comparator group

Treatment:

Drug: Placebo