Clinical trial NCT00293176: The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
Official title: A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Memory Loss
Keywords: Cognitive impairment
Memory Loss
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2006-02-17
Enrollment: 821
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of cognitive and global function in subjects with MCI.
Secondary outcomes:
measure: Behavioral, global and cognitive outcomes; Neuroimaging
Other outcomes:
Locations:
city: Albaster
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Irvine
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Fort Meyers
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Snellville
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Elkhart
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Farmington Hills
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Kenilworth
country: United States
state: New Jersey
city: Long Branch
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Lexington
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: No. Charleston
country: United States
state: North Carolina
city: Centerville
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Greensberg
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Madison
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bennington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Eisai Inc.
name: Anita Murthy
role: STUDY_DIRECTOR
References: