The purpose of this study will be to investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior. Brain imaging will also be performed in some subjects.

Condition	Treatment or Intervention	Phase
Memory Loss	Drug: Donepezil Hydrochloride	Phase IV

Further Study Details: 

Primary Outcomes: Assessment of cognitive and global function in subjects with MCI
Secondary Outcomes: Behavioral, global and cognitive outcomes; Neuroimaging
Expected Total Enrollment:  550

Ages Eligible for Study:  45 Years   -   90 Years,  Genders Eligible for Study:  Both

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

Anita Murthy, Pharm.D.       anita_murthy@eisai.com
Nicola Lynch       nicola_lynch@eisai.com

Alabama
      Albaster,  Alabama,  United States; Recruiting
Arizona
      Peoria,  Arizona,  United States; Recruiting
      Mesa,  Arizona,  United States; Recruiting
      Sun City,  Arizona,  United States; Recruiting
      Tucson,  Arizona,  United States; Recruiting
California
      Sacramento,  California,  United States; Recruiting
      Irvine,  California,  United States; Recruiting
      San Francisco,  California,  United States; Recruiting
      Fresno,  California,  United States; Recruiting
      Irvine,  California,  United States; Recruiting
      San Diego,  California,  United States; Recruiting
      San Diego,  California,  United States; Recruiting
      Garden Grove,  California,  United States; Recruiting
Colorado
      Denver,  Colorado,  United States; Recruiting
Connecticut
      New Haven,  Connecticut,  United States; Recruiting
Florida
      Venice,  Florida,  United States; Recruiting
      West Palm Beach,  Florida,  United States; Recruiting
      Jacksonville,  Florida,  United States; Recruiting
      Fort Lauderdale,  Florida,  United States; Recruiting
      Ocala,  Florida,  United States; Recruiting
      Sarasota,  Florida,  United States; Recruiting
      St. Petersburg,  Florida,  United States; Recruiting
      West Palm Beach,  Florida,  United States; Recruiting
      Tampa,  Florida,  United States; Recruiting
      Fort Meyers,  Florida,  United States; Recruiting
      Hollywood,  Florida,  United States; Recruiting
      North Miami,  Florida,  United States; Recruiting
      Sarasota,  Florida,  United States; Recruiting
      Boynton Beach,  Florida,  United States; Recruiting
      Melbourne,  Florida,  United States; Recruiting
Georgia
      Snellville,  Georgia,  United States; Recruiting
Illinois
      Chicago,  Illinois,  United States; Recruiting
Indiana
      Elkhart,  Indiana,  United States; Recruiting
Kentucky
      Paducah,  Kentucky,  United States; Recruiting
Louisiana
      New Orleans,  Louisiana,  United States; Recruiting
Michigan
      Farmington Hills,  Michigan,  United States; Recruiting
      Kalamazoo,  Michigan,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Kenilworth,  New Jersey,  United States; Recruiting
      Long Branch,  New Jersey,  United States; Recruiting
New York
      New York,  New York,  United States; Recruiting
      Lexington,  New York,  United States; Recruiting
      Albany,  New York,  United States; Recruiting
      Rochester,  New York,  United States; Recruiting
      Staten Island,  New York,  United States; Recruiting
North Carolina
      No. Charleston,  North Carolina,  United States; Recruiting
Ohio
      Cleveland,  Ohio,  United States; Recruiting
      Toledo,  Ohio,  United States; Recruiting
      Centerville,  Ohio,  United States; Recruiting
Oregon
      Medford,  Oregon,  United States; Recruiting
      Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  United States; Recruiting
      Greensberg,  Pennsylvania,  United States; Recruiting
Rhode Island
      Providence,  Rhode Island,  United States; Recruiting
Tennessee
      Madison,  Tennessee,  United States; Recruiting
Texas
      Houston,  Texas,  United States; Recruiting
      Houston,  Texas,  United States; Recruiting
      San Antonio,  Texas,  United States; Recruiting
      Wichita Falls,  Texas,  United States; Recruiting
      Austin,  Texas,  United States; Recruiting
Utah
      Salt Lake City,  Utah,  United States; Recruiting
Vermont
      Bennington,  Vermont,  United States; Recruiting
Virginia
      Charlottesville,  Virginia,  United States; Recruiting
Washington
      Seattle,  Washington,  United States; Recruiting

Study ID Numbers:  E2020-A001-412
Record last reviewed:  December 2004
Last Updated:  January 21, 2005
Record first received:  December 22, 2004
ClinicalTrials.gov Identifier:  NCT00100022
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08