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MILD COGNITIVE IMPAIRMENT STUDY - ADCS Clinical Trial (no longer enrolling)

What is the main objective of this study?
The main objective of this study is to evaluate the efficacy and safety of 1,000 IU of vitamin E bid or 10 mg of donepezil, administered daily, to delay the clinical diagnosis of Alzheimer's disease when administered orally, to 720 individuals with mild cognitive impairment for thirty six months. Efficacy will be determined by comparing the rate of conversion to AD for vitamin E or donepezil to that observed with placebo.

What is the secondary objective of this study?
The other objective of this study is to evaluate the efficacy of vitamin E and donepezil on cognition in MCI subjects.

How will this study be conducted?
This study is a randomized, double-blind, placebo-controlled, balanced, parallel-group design.

How many patients will be participating in this study?
Approximately 720 participants (n=240 subjects per group) from 60-80 centers in North America (USA and Canada) will be participating in the study.

Who is eligible to participate in this study?
The following are the eligibility criteria for this study:
  • Men and women aged 55 to 90
  • Have mild cognitive impairment (cognitive impairment of insufficient severity to make a diagnosis of Alzheimer's disease)
  • Included subjects will have a clear memory deficit, but without major impairments in other cognitive domains

What will the statistical analysis be used to determine?
The primary analysis will be a classic intent-to-treat analysis. The primary analysis will determine if there is a significant reduction in the rate of conversion to AD in subjects treated with high dose vitamin E or donepezil as compared to placebo.

How can I enroll in this study?
The MCI study has recently completed active enrollment of patients.



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