Moderate-to-Severe Alzheimer's Disease Study

The goal of this double-blind study is to compare a 23-mg sustained release version of donepezil to currently marketed 10-mg immediate release donepezil in the treatment of patients with moderate to severe Alzheimer’s disease. This study will test whether the higher dose of donepezil (23mg) will help maintain memory, behavior, activities of daily living, and global function in individuals with moderate to severe Alzheimer’s disease compared to the current Food and Drug Association approved dose of 10mg. It will also determine if the sustained release version will have a better side-effect profile than the currently available immediate release version.

The study, which is being conducted by the Rush Alzheimer’s Disease Center (one of 105 sites around the country), is sponsored and funded by Eisai Limited.

Duration of the study is 24 weeks. Eligible participants will receive 23mg of sustained release donepezil or 10mg of immediate release donepezil. At the end of the study, participants may have an opportunity to participate in an open-label extension study of the medications.

Each clinic visit will be a combination of all or some of the following: memory testing, neurological exams, blood draws, ECG recordings, as well as quality of life, neuropsychological and activities of daily living questionnaires.

There will be no cost to people who join the study. The medication and all visits will be covered by the research study.

You may be eligible to participate in this study if you:

Are between 45 and 90 years of age
Have a diagnosis of mild to moderate Alzheimer’s disease [Mini-Mental State Examination (MMSE) score less than or equal to 20 out of 30]
Have been on a stable dose of 10mg of donepezil (Aricept) for at least 3 months
Speak English or Spanish
Have a friend or family member who will accompany the subject to all study visits and meet caregiver inclusion criteria for memory and mood

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.