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

Last updated on May 11, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
A Randomized Double-Blind, Parallel, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil (5 mg QD for 6 Weeks) After Single Dose and Steady State Therapy (2 Weeks and 6 Weeks) in Subjects With Mild Cognitive Impairment
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer's Disease
Drug: donezepil (Aricept)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2007
Not Provided

Inclusion Criteria:

  • 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:

  • 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
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00483028
A9001134
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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