Implementing a Memory Clinic Model to Facilitate Recruitment into Early Phase Clinical Trials for Mild Cognitive Impairment and Alzheimer’s Disease

Abstract

Background

The recruitment challenges for MCI and AD subjects into clinical trials are well known, and this is particularly true for early phase studies. Currently, only 10-20% of all patients who are referred for research from the community are trial eligible (Grill and Karlawish, 2011). Due to the limited and specific study objectives in early phase study designs, these rates drop to approximately one patient every two months. Barriers to research recruitment are multi-factorial, involving patient centered factors, issues related to caregiver/study partner participation, and aspects related to the involvement of their treating physicians. To address this challenge, we implemented a Memory Clinic within PAREXEL’s Early Phase Clinical Pharmacology Unit. Our objective was to significantly facilitate recruitment into AD clinical trials by providing resources and education to patients, their treating physicians, and caregivers in the community.

Method

The Clinic’s primary goals were to increase research visibility and partnerships with local organizations and referring physicians. Members of the research team co-sponsored community outreach events with local organizations, thereby increasing awareness about the services of this memory clinic. Secondly, physician outreach was expanded to include those who were not previously amenable to clinical trial referrals. Finally, Memory Clinic patients were given clinical evaluations, free of charge and the results were discussed with the patients and their caregivers. If the patients were interested in hearing more about possible research opportunities, they were referred to the early phase unit for a screening visit.

Results

We found that new referrals for research participation significantly increased as a result of this new paradigm. In 2016, 12 patients diagnosed with MCI or AD per protocol, were referred to a research study and 3 were randomized. In 2017, 98 patients were referred and 16 were enrolled In addition, our referral network increased with 30 physicians over a 20 mile radius. Collaborations with national non-profit organizations also increased, thereby increasing public awareness about the importance of research participation in the development of new treatments for Alzheimer’s Disease.

Conclusions

In summary, community engagement and providing referring physicians with a clinical service improved recruitment significantly for our phase 1 unit. Resource education, staff training, and dedicated medical professionals can significantly improve awareness about clinical research participation and provide additional participants over and above traditional recruitment methods and trial registry enrollment in a large urban area.