Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled,
36-month study comparing the length of time of progression from mild cognitive impairment
(MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs.
placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a
treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40
countries for Alzheimer's disease to date, including all 15 member states of the European
Union, New Zealand, Argentina, Brazil and Mexico.
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo.
Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day)
for the majority of the study. At every regular visit scheduled every three months, patients
will be given basic efficacy and safety assessments. These assessments will include
evaluation of adverse events, vital signs, activities of daily living, and clinical staging
scales to determine if the subject may have converted to dementia.
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