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Clinical Trails at Rush Alzheimer's Medical Food Study
Clinical Trial Protocol ID
09010704

Clinical Trial Investigator Name
Raj Shah

Clinical Trial Title

Study to assess the efficacy of a medical food in patients already using an FDA approved medication for the treatment of mild-to-moderate Alzheimer's disease



Clinical Trial Protocol Description

Souvenaid® with Fortasyn™ Connect is a once-a-day multi-nutrient drink intended as a medical food for the dietary management of Alzheimer's disease (AD).  The goal of this study is to determine whether the multi-nutrient drink is safe and effective in patients with mild-to-moderate AD.

The study is being conducted by the Rush Alzheimer's Disease Center.  It is sponsored and funded by Danone Research. Nationwide, 500 individuals will be recruited for the study. At Rush, we expect to recruit approximately 20 individuals.

Duration of the study is 7 months with 5 evaluation visits. Eligible participants will receive Souvenaid® with Fortasyn™ Connect or placebo to consume daily.

Each evaluation visit will be a combination of all or some of the following: testing of memory, mood, and function; vitals; and blood draws.

There will be no cost to participants who volunteer. The study drink and all visits will be covered by the research study.



Clinical Trial Eligibility Criteria

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

  • Are clinically diagnosed with mild-to-moderate Alzheimer's disease
  • Are taking an FDA approved  medication for Alzheimer's disease (Aricept, Exelon, Razadyne, and/or Namenda) for the past 4 months
  • Are 50 years of age or older
  • Are able to have a caregiver or study partner be with you during all study visits and telephone calls

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.





Contact Name Katelin Shields
Contact Phone (312) 942-2312
Contact E-mail clinical_trials@rush.edu
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