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Completed

NCT Number: NCT00483028

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

To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

donezepil (Aricept)

Drug

Primary outcomes

  1. Neuropsychologic test scores: GMLT, DSST, Cog State TM including PAL test, RAVLT, ADAS-cog at baseline (pre-dose) 5 and 8 hours after the first dose and 2 and 6 weeks. (Continues in next bullet.)

  2. MRS (Magnetic Resonance Spectroscopy) profile including but not limited to NAA (N-acetyl-aspartate), NAA/Cr (N-acetyl-aspartate/creatinine ratio), MI (Myoinositol) and MI/Cr (Myoinositol/creatinine ratio).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Jun 6, 2007
Registry last updated
Feb 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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