In 2019, multiple high-profile Alzheimer’s clinical trials ended earlier than planned after interim results suggested that the potential benefits no longer outweighed the risks, either due to futility or safety concerns. Sponsors had communication plans in place, but many research participants and study partners — knowledgeable informants who enroll in research with the participant and can provide information about their cognition and function — learned about the early termination of their studies through news coverage rather than through direct communication from study personnel.

The understandable disappointment of participants and study partners resulted in calls from within the Alzheimer’s and related dementia research community to identify better ways to communicate with and support participants and study partners when trials end early.

Participant FIRST

The Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Workgroup was created to address these concerns and first met in January 2021. The multidisciplinary work group included research participants and their study partners, researchers and study personnel, as well as representatives from academia, industry, patient advocacy organizations and the National Institutes of Health.

Members meet regularly to describe the central issues, define the limitations of current approaches, and develop and refine recommendations.

An article published in Alzheimer's & Dementia®: The Journal of the Alzheimer's Association provides background and recommendations on how to improve communication with research participants and their study partners in the event a trial is discontinued, and better provide support when trials end early.

Learn more: When Clinical Trials End

Participant FIRST Workgroup recommendations


  • Sponsors and funders should provide resources and funding in the study budget to ensure orderly trial closeout.
  • Sponsors or principal investigators should ensure that the communication plan developed for the trial addresses the possibility of early stoppage.
  • Study personnel must address the possibility of early stoppage during the informed consent process.
  • General information about early stoppage should be available to members of the public.
  • Study personnel should encourage participants and study partners to build and sustain their support networks.


  • Study personnel should regularly check and update contact information for participants and study partners.
  • Study personnel should remind participants and study partners that clinical trials might end early.
  • Sponsors and principal investigators should anticipate and proactively address participants' and study partners’ questions and concerns when there is news from related clinical trials.


  • If a sponsor announces early stoppage via a press release, that press release should explicitly address participants and study partners.
  • The sponsor or principal investigator should communicate news of early stoppage to site investigators and study personnel.
  • Upon learning of early stoppage, study sites should initially contact participants via email as soon as possible.
  • As soon as possible after the initial notification email is sent, study personnel should call participants and study partners and personally inform them that the trial has stopped.
  • Sponsors, principal investigators and study sites should consider leveraging social media to disseminate consistent information about early stoppage to participants and study partners.
  • Sponsors and principal investigators should collaborate with patient advocacy organizations to support participants and study partners when trials end early.
  • Sponsors should prepare answers to FAQs and disseminate them broadly.
  • Site investigators should invite participants and study partners to a personalized closeout meeting to cover information like participant arm assignment.
  • Sponsors or principal investigators and sites should collaborate to ensure top-line results are shared with participants and study partners.

Professional Interest Area

Building off of the success of the Participant FIRST workgroup, and to continue future efforts in this area, there is a new Partnering with Research Participants Professional Interest Area (PIA) for researchers and clinical trial participants within the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART).

A global forum is needed for researchers to share best practices on how to partner with participants, as well as opportunities to learn directly from the lived experiences of a diverse group of research participants. The Partnering with Research Participants PIA will work with existing PIAs and leverage existing groups to ensure broad access and applicability.

Workgroup members

Pam Montana
Person Living with Alzheimer's Disease

Ed Patterson
Person Living with Alzheimer's Disease

Nancy Childs, Ph.D.
Care Partner

David Sims
Care Partner

Rebecca M. Edelmayer, Ph.D.
Alzheimer’s Association

Stephen Hall, MPH
Alzheimer’s Association

Monica Moreno
Alzheimer’s Association

Penny Dacks, Ph.D.
Association for Frontotemporal Degeneration

Shana Dodge, Ph.D.
Association for Frontotemporal Degeneration

Angela Taylor
Lewy Body Dementia Association

Bernadette Siddiqi, MA
Michael J. Fox Foundation for Parkinson’s Research

Erin Iturriaga, DNP, MSN, RN
National Institutes of Health, National Heart, Lung, and Blood Institute

Nadezda Radoja, Ph.D.
National Institutes of Health, National Institute on Aging

Laurie M. Ryan, Ph.D.
National Institutes of Health, National Institute on Aging

Jessica Langbaum, Ph.D.
Banner Alzheimer’s Institute

Kathleen A. Welsh-Bohmer, Ph.D.
Department of Psychiatry, Duke University School of Medicine

Jonathan Jackson, Ph.D.
Department of Neurology, Massachusetts General Hospital, Harvard Medical School

Thomas O. Obisesan, M.D., MPH
Division of Geriatrics, Department of Medicine, Howard University and Hospital

Rachel L. Nosheny, Ph.D.
Department of Psychiatry and Behavioral Sciences, University of California San Francisco, VA Advanced Imaging Research Center, San Francisco Veterans Administration Medical Center

Rueben C. Warren, D.D.S, MPH, DrPH., M.Div.
National Center for Bioethics in Research and Health Care, Tuskegee University

Emily A. Largent, JD, Ph.D., RN
Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine

Sarah Walter, M.Sc.
Alzheimer’s Therapeutic Research Institute, University of Southern California

Jorge J. Llibre Guerra, M.D., M.Sc.
Department of Neurology, Washington University School of Medicine in St.Louis

Elena Portacolone, Ph.D., MBA, MPH
Institute for Health & Aging, Philip Lee Institute for Health Policy Studies

Hana Florian, M.D.

Poorvi Chablani

Liz Mascherino

Stacie Weninger, Ph.D.

David S. Miller, M.D., MA
Signant Health

Resources for clinical trial participants