Challenging Patient Population

Central Nervous System

CHALLENGING PATIENT POPULATION

SPONSOR

This study is sponsored by a biopharmaceutical company who is partnered with a fortune 500 company on the development of this study drug with a unique mechanism of action in Alzheimer’s disease.

PROJECT

A Phase 3 multi-center trial, 12 month safety and efficacy study evaluating an oral study medication in patients with mild to moderate Alzheimer’s disease. Over 1000 patients enrolled across 120+ sites in 10 countries worldwide with approximately 60 sites in the United States. Patients will be followed for 12 months of study treatment and offered open label study drug at the end of that time for a period of at least one year after which minimal evaluations will be required and patients will be followed for safety.

CHALLENGE

How do you ensure compliance and retention in a patient population that is dependent on caregiver assistance? This patient population has many obstacles to address when committing to a year-long study. Our experienced staff helps sites address those obstacles and find unique ways of helping patients and their caregivers comply with study visits and study requirements.

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RESULTS

ProTrials has worked closely with each site to ensure optimal patient retention and compliance. If a patient is considering withdrawing from the study, we proactively work with the site to determine the reason for a possible withdrawal and in many instances are able to overcome those obstacles (e.g., transportation issues).

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SPONSOR FEEDBACK

“We have worked with ProTrials for years across multiple programs and value their expertise, flexibility and responsive customer service. ProTrials’ seasoned professionals have contributed both domestically and internationally, in-house and in the field, whatever our needs have been ProTrials has been our solution!”

-Sponsor, Sr. Director, Clinical Operations