The National Institute on Aging (NIA) and the Alzheimer’s Association convened workgroups who published diagnostic guidelines in 2011 across the disease continuum (preclinical due to AD, mild cognitive impairment due to AD, dementia due to AD) and a research framework for moving forward the hypothesis of AD as a biological disease in 2018. Read the 2018 research framework and the 2011 clinical guidelines.
These efforts have supported recommendations for the diagnosis and characterization of Alzheimer’s disease (AD). Several core principles emerged from these efforts, including:
In early 2022, the Alzheimer’s Association convened a steering committee — chaired by Dr. Clifford Jack, Mayo Clinic — to lead the translation of the 2011 diagnostic guidelines and the 2018 research framework into the newly proposed diagnostic criteria. These new criteria do not constitute clinical practice guideline recommendations.
The workgroup, under the leadership of Dr. Clifford Jack, presented their work at the Alzheimer’s Associations International Conference (AAIC) 2023 for scientific input and review until Aug. 31, 2023. The draft of the workgroup recommendations was compiled prior to the AAIC presentation.
Updates and adjustments have been made, which reflect feedback and input received in response to the initial draft (PDF). Updates made to the revised draft were shared during a session at the Clinical Trials on Alzheimer's Disease (CTAD) conference on Oct. 25.
A draft of the Revised Criteria for Diagnosis and Staging of Alzheimer's Disease: Alzheimer's Association Workgroup (PDF) and its figures and tables (PDF) — updated October 2023 — are available.
The comment period is now closed. The workgroup will review all submitted comments and work to finalize the documents for submission in a research/medical journal in early 2024. View the comments submitted in round 2. There will be sessions at upcoming scientific conferences sharing the revised criteria throughout 2024, including ADPD and AAIC 2024. Please contact Heather Snyder at firstname.lastname@example.org with questions.
Note: The National Institutes of Health has asked the Alzheimer's Association to remove the NIA from the formal title of the revised diagnostic criteria. The NIA will continue to work with the criteria workgroup in collaboration as advisers. Read the NIA's comment.
First, no disease targeted therapies had received regulatory approval in 2018, but since then, several have. In response, the present document has progressed from a framework for research to criteria for diagnosis and staging that are intended for clinical use as well as research.
Second, validated biomarkers in 2018 were based on either CSF assays or imaging. Since then, plasma-based biomarkers with excellent diagnostic performance have been developed and clinically validated. The present document has correspondingly incorporated plasma biomarkers into updated criteria for biomarker categorization, disease diagnosis and staging.
Third, research studies have demonstrated that imaging and fluid biomarkers within a category are not equivalent for many use cases. In the present document we have updated biomarker classification criteria to accommodate nonequivalence between fluid and imaging biomarkers within a category.
The Alzheimer's Association formed the workgroup whose charge was to examine the 2018 research framework and the 2011 clinical guidance in the context of current scientific knowledge and, if appropriate, update them. Workgroup members were selected to achieve a range of scientific expertise, the broad representation of different institutions (public, academic and private) and professional organizations involved with AD research, and geographic and gender diversity. Given the importance of the criteria to support research studies testing clinical interventions, scientific expertise included regulatory science via a representative of the U.S. Food & Drug Administration. The process of criteria development included public comments at CTAD 2023 and other meetings, a website providing the most recent draft, and the opportunity for web-based feedback. The website will remain open for comment through the writing stage as well as post-publication. View each workgroup member's disclosures (PDF).
Jeffrey Scott Andrews, PharmD
Thomas G. Beach, M.D., Ph.D.
Banner Sun Health Research Institute
Teresa Buracchio, M.D.
U.S. Food and Drug Administration
Maria C. Carrillo, Ph.D.
Alzheimer’s Association, convener and steering committee
Billy Dunn, M.D.
Independent, steering committee
Ana Graf, M.D.
Oskar Hansson, M.D., Ph.D.
Carole Ho, M.D.
Clifford R. Jack Jr., M.D.
Mayo Clinic, chair and steering committee
William Jagust, M.D.
University of California, Berkeley
Eliezer Masliah*, M.D.
National Institutes of Health, steering committee
Eric McDade, D.O.
Washington University in St. Louis
José Luis Molinuevo, M.D., Ph.D.
Ozioma Okonkwo, Ph.D.
University of Wisconsin, Madison
Luca Pani, M.D.
University of Miami, Former Italian Regulatory Agency
Michael Rafii, M.D., Ph.D.
University of Southern California
Laurie Ryan*, Ph.D.
National Institute on Aging
Phillip Scheltens, M.D., Ph.D.
Life Science Partners
Eric Siemers, M.D.
Heather Snyder, Ph.D.
Reisa Sperling, M.D.
Brigham and Women’s Hospital, Harvard
Charlotte E. Teunissen, Ph.D.
VU University Medical Center
* Advisory member of the workgroup