Increasing enrollment in Alzheimer’s disease, other clinical trialsJanuary 31, 2013
The goals of the new National Plan to Address Alzheimer’s Disease include increasing recruitment into clinical trials for Alzheimer’s and other dementias. As a first step, NIA is seeking information on Increasing Enrollment in Alzheimer’s Disease and Related Clinical Trials and Studies. We are looking for input from a wide range of interested parties, including health professionals, aging research organizations, advocacy groups, Alzheimer’s Disease Centers, Alzheimer’s Disease Cooperative Study coordinators and investigators, key federal agencies, and international groups involved in Alzheimer’s research. There is a particular need for information about strategies effective in reaching out to racial and ethnic minorities. The goal is to develop strategies to increase enrollment and retention in clinical studies, through the development of registries, overcoming barriers to participation, or other considerations. Responses to the formal Request for Information are invited. The recommendations and insights submitted by the larger Alzheimer’s disease community will inform follow-on meetings and discussions aimed at expanding trial participation.
New funding for the Alzheimer’s Disease Cooperative Study
The NIA has renewed its support of the Alzheimer’s Disease Cooperative Study (ADCS) with an $11 million award in FY 2013 and as much as $55 million planned over 5 years of the project. The award makes possible four new Alzheimer’s clinical trials that will: test a medication to reduce agitation in people with Alzheimer’s dementia, test a cutting-edge approach to speed drug testing in clinical trials, explore whether exercise can influence Alzheimer’s pathology and improve cognition, and test an amyloid-clearing drug in people at the presymptomatic stage of Alzheimer’s. Significantly, several of the trials will recruit presymptomatic study participants to understand how disease develops and the influence of interventions in the earliest stages of Alzheimer’s. Read more about the new ADCS studies.
NIH offers resources for clinical trials outreach
Clinical research is vital to the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. Only through clinical research will we learn about the safety and effectiveness of potential new therapies. The challenge of recruiting clinical trial participants has serious implications for the success or failure of research, with some special issues in Alzheimer’s disease research.
Studies have shown that health care providers play an important role in raising awareness and presenting the option of clinical trial participation. A focused conversation about treatment options including clinical trials can help make patients aware and, further, invite them to enroll in a clinical research study. In fact, participating patients are more likely to first learn about clinical trials through a doctor, have a doctor explain the pros and cons of participation, and find an appropriate trial with the help of their health care provider.
Providing information to help individuals make decisions about research involvement promotes understanding of the true benefits and risks of participation. It also increases awareness about the importance of clinical research.
To help the public learn more about participating in clinical research, NIH created the resource NIH Clinical Research Trials and You. The website includes personal stories from study participants, information about how to find a clinical trial, and educational resources for health care providers and the public.
Among the materials included on the NIH website is the NIA fact sheet Participating in Alzheimer's Disease Clinical Trials and Studies, which describes Alzheimer’s disease clinical trials and studies, explains their scientific design, and offers key facts and questions to consider about volunteering for clinical research. To search for Alzheimer’s clinical trials, go to www.nia.nih.gov/alzheimers/clinical-trials.
Page last updated: April 1, 2013