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A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

Last updated on February 17, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy males or females ages 55-90 inclusive (Healthy is defined as no clinically
relevant abnormalities identified by a detailed medical history, full physical
examination, including blood pressure and heart rate measurement, 12-lead ECG and
clinical laboratory tests)

- Body Mass Index (BMI) between 18 to 34 kg/m2, inclusive; and a total body weight

- Subjects with mild cognitive impairment (MCI) must have a reliable informant who has
an average of 10 hours per week or more contact with the subject.

- Memory complaints and memory difficulties, which are verified by an informant

- Mini-mental status exam (MMSE) score of 24-30

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with known hypersensitivity to donepezil hydrochloride or to piperidine
derivatives

- Insulin-requiring diabetes or uncontrolled diabetes mellitus

- Subjects with a current diagnosis of depression or other psychiatric illnesses

NCT00483028
Pfizer
Completed
A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

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[email protected]

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