A Consensus Statement on the Request to Approve Aducanumab in Canada

On June 7^th, 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab (marketed as Aduhelm), which is a possible treatment or disease-modifying therapy for early-stage Alzheimer’s disease (AD). The FDA approval has been met with controversy. Around the world, clinicians and researchers working in AD and dementia have raised questions and concerns.

The TDRA and the Tanz Centre for Research in Neurodegenerative Diseases produced a joint statement on the FDA approval of aducanumab.

In addition, aducanumab is now under review for approval in Canada. In response, six Canadian dementia and AD-focused scientific organizations (listed below), including the TDRA, came together to develop a consensus statement. These organizations represent a large network of expert clinicians and researchers from across Canada.

The consensus statement has been submitted to Health Canada, the governing body responsible for authorizing the use of new drugs in Canada. The statement put forth aims to help guide the decisions on the approval of aducanumab for use in Canada.

Read a summary of the concerns expressed in the statement and the actions taken. 

Additional Resources

Clinical Consensus Statement

Press Release

Signatories

The organizations who prepared and endorse the consensus statement include:

• The Canadian Consortium on Neurodegeneration in Aging (CCNA)
• The Consortium of Canadian Centres for Clinical Cognitive Research (C5R)
• The Canadian Academy of Geriatric Psychiatry (CAGP)
• The Canadian Geriatrics Society (CGS)
• The Ontario Neurodegenerative Disease Research Initiative (ONDRI)
• The Toronto Dementia Research Alliance (TDRA)

Individual signatories:

Shabbir Amanullah, DPM, MD, FRCPsych (UK), CCT (UK), FRCPC, DFCPA, FIIOPM
Also on behalf of the Canadian Academy of Geriatric Psychiatry (CAGP)
President, CAGP
Chief of Psychiatry, Woodstock General Hospital
Adjunct Professor, University of Toronto and Western Ontario

Sandra Black, O.C., O.Ont., Hon. DSc., MD, FRCP(C), FRSC, FAAN, FAHA, FANA
Professor of Medicine (Neurology), Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto
Hurvitz Brain Sciences Research Program Director, Sunnybrook Research Institute
Scientific Director, Dr. Sandra Black Centre for Brain Resilience and Recovery
Site Leader, Heart and Stroke Foundation Canadian Partnership for Stroke Recovery

Christian Bocti, MD, FRCPC
Full Professor, Department of Medicine
Division of Neurology and Research Center on Aging.
Faculty of Medicine and Health Sciences
Université de Sherbrooke

Michael Borrie, MB ChB, FRCPC
Geriatrician and Professor at Western University, Schulich School of Medicine and Dentistry, Department of Medicine, Division of Geriatric Medicine
Past President, C5R

Howard Chertkow, MD, FRCP, FCAHS
Also on behalf of the Canadian Consortium on Neurodegeneration in Aging (CCNA)
Scientific Director, CCNA
Senior Scientist and Chair in Cognitive Neurology and Innovation, Rotman Research Institute, Baycrest Health Sciences
Director, Kimel Centre for Brain Health and Baycrest Clinical Trials Unit;
Affiliate Member, Dept. of Neurology, McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital

Howard Feldman, MDCM FRCP(C)
Professor, Department of Neurosciences, University of California San Diego (UCSD)
Director, ADCS (Alzheimer Disease Cooperative Study), UCSD
Dean for Alzheimer’s and Related Neurodegenerative Research, UCSD

Morris Freedman, MD, FRCPC
Head, Division of Neurology, Baycrest
Scientist, Rotman Research Institute, Baycrest,
Professor, Faculty of Medicine (Neurology), University of Toronto
Medical Director, Cognition & Behaviour, Baycrest

David Hogan, MD, FACP, FRCP
Professor, Division of Geriatric Medicine, Cumming School of Medicine, University of Calgary
Academic Lead, Brenda Strafford Centre on Aging, O’Brien Institute for Public Health, University of Calgary

Robin Hsiung, MD, MHSc, FRCPC, FACP, FAAN
Also on behalf of the Consortium of Canadian Centres for Clinical Cognitive Research (C5R)
President, C5R
Associate Professor in the Division of Neurology Department of Medicine, University of British Columbia

Andrew Kirk, MD, FRCPC
Professor of Neurology, University of Saskatchewan

Mario Masellis, MD, PhD
Also on behalf of the Ontario Neurodegenerative Disease Research Initiative (ONDRI)
Co-Lead, ONDRI
Associate Scientist, Evaluative Clinical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute
Associate Professor, Medicine (Neurology), University of Toronto
Research Scientist, Neurogenetics, Centre for Addiction and Mental Health
Clinician-scientist, Neurology, Department of Medicine, Sunnybrook Health Sciences Centre
Director, Cognitive & Movement Disorders Clinic, Department of Medicine, Sunnybrook

Manuel Montero-Odasso, MD, PhD, FRCPC, AGSF, FGSA
Also on behalf of the Canadian Geriatrics Society (CGS)
Vice-President, CGS
Professor in the Departments of Medicine, Epidemiology and Biostatistics, University of Western Ontario
Director of the “Gait & Brain Lab” at Parkwood Institute, London, Ontario
Geriatrician and clinician-scientist at the Lawson Health Research Institute

Haakon Nygaard, MD, PhD
Assistant Professor, Division of Neurology
Charles E. Fipke Professor of Alzheimer’s Research
Director, UBC Hospital Clinic for Alzheimer Disease and Related Disorders, University of British Columbia

Natalie Phillips, PhD
Also on behalf of the Canadian Consortium on Neurodegeneration in Aging (CCNA)
Associate Scientific Director, CCNA
Professor in the Department of Psychology, Concordia University
Concordia University Research Chair (Tier 1) in Sensory-Cognitive Health in Aging and Dementia
Neuropsychologist and Project Director at the Lady Davis Institute for Medical Research
Member of the Centre for Research in Human Development and the Centre for Research on Language Mind and Brain
Cross-appointed to the Department of Clinical Neurosciences in the Jewish General Hospital

Kenneth Rockwood, MD, MPA, FRCPC, FRCP
Also on behalf of the Canadian Consortium on Neurodegeneration in Aging (CCNA)
Associate Scientific Director, CCNA
Senior Medical Director, Frailty/Elder Care Network, and Staff Physician, Nova Scotia Health
Professor of Medicine (Geriatric Medicine and Neurology) and Kathryn Allen Weldon Professor of Alzheimer Research, Dalhousie University

Tarek Rajji, MD, FRCPC
Also on behalf of the Toronto Dementia Research Alliance (TDRA)
Executive Director, TDRA
Professor, Department of Psychiatry, University of Toronto
Canada Research Chair in Neurostimulation for Cognitive Disorders
Chief, Adult Neurodevelopment and Geriatric Psychiatry Division
Centre for Addiction and Mental Health

Louis Verret, M.D., FRCPC, neurologue
Diplômé en neurologie comportementale et neuropsychiatrie (United Council for Neurological Subspecialities)
Professeur de clinique, Faculté de médecine, Université Laval
Directeur, Clinique interdisciplinaire de mémoire (CIME) du CHU de Québec, Université Laval

Marie-Jeanne Kergoat, MD, PhD
Geriatrician
Director, Cognition Clinic and Specialized Medicine Services, Institut universitaire de gériatrie de Montréal, Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de-l’Ile-de-Montréal
Co-Lead, CIMA-Q
Full Professor of Medicine, Université de Montréal
Signed on behalf of CIMA-Q (added July 22, 2021)