1st Edition
Trial Designs and Outcomes in Dementia Therapeutic Research
Given the increased attention by clinicians, researchers and the pharmaceutical industry to the management and treatment of dementia not only in the elderly but also in increasingly younger populations, the demands for effective evidence-based pharmaceutical control of dementia and quantitative assessment of outcomes have increased. Since some first steps in the early 1960's to the controversial landmark paper of Summers and colleagues, to the most recent trials, it is clear both that much progress has been made, and that much remains to be done. This book is written to take stock of what is now usefully known, and to speculate on directions for the future.
Short Contents
Kenneth Rockwood (Halifax, Canada)
The history of therapeutic trials in dementia
Peter Whitehouse (Cleveland, USA)
Treatment hypotheses
Gordon Wilcock (Bristol, UK)
Clinical trial designs and end-point selection
Serge Gauthier (Montreal, Canada) & Chris MacKnight (Halifax, Canada)
The use of qualitative research in anti-dementia drug trials
Christine Joffres & Kenneth Rockwood (Halifax, Canada)
Inclusion and exclusion criteria
David Hogan (Calgary, Canada)
Global assessment measures for anti-dementia drug trials
Kenneth Rockwood (Halifax, Canada)
Cognitive outcomes
Neelesh Nadkarni and Sandra E. Black (Toronto, Canada)
Functional outcomes
Serge Gauthier (Montreal, Canada)
Behavioral outcomes in trials of cognitive agents
Clive Ballard (Newcastle, UK)
Quality of life outcomes
Kenneth Rockwood (Halifax, Canada)
Caregiver burden outcomes
Henry Brodaty and Claire Thompson (Sydney, Australia)
Neuroimaging outcomes
Philip Scheltens and F Barkhof (Amsterdam, the Netherlands)
Guidelines for randomized clinical studies in Parkinson’s Disease with Dementia and Dementia with Lewy Bodies
Richard Camicioli (Edmonton, Canada) and Serge Gauthier (Montreal, Canada)
Lessons from clinical trials in vascular cognitive impairment
Kenneth Rockwood & Gordon Gubitz (Halifax, Canada)
Lessons from primary prevention trials in dementia
Ingmar Skoog and Deborah Gustafson (Göteborg, Sweden)
Lessons from trials in moderate to severe dementia
Michael Borrie and Matthew Smith (London, Canada)
Lessons from trials of psychotropic agents in Alzheimer’s disease
David M. Blass and Peter V. Rabins (Baltimore, USA)
Lessons from psychosocial interventions aimed at caregivers of people with dementia
Stanford P. Newman and Georgina Charlesworth (London, UK)
Pharmacoeconomic outcomes
Anders Wimo and Bengt Winblad (Stockholm, Sweden)
Executive Dysfunction in Dementia
Roger Bullock and Sarah Voss (Swindon, UK)
Ethical considerations in the conduct of clinical trials for Alzheimer’s Disease
John Fisk (Halifax, Canada)
Designs for trials when there is a standard therapy: superiority, equivalence and non-inferiority
David L. Streiner (Toronto, Canada)
Conclusions: Lessons from clinical trials in dementia
Kenneth Rockwood (Halifax, Canada) & Serge Gauthier (Montreal, Canada)
Biography
Kenneth Rockwood MD MPA FRCPC is Professor, Division of Geriatric Medicine, Department of Medicine and Kathryn Allen Weldon Professor of Alzheimer Research, Dalhousie University, Halifax NS, Canada. Serge Gauthier MD FRCPC is Professor and Director of the Alzheimer’s Disease Research Unit, The McGill Centre for Studies in Aging (Le Centre McGill D’Études sur le Vieillissement), Douglas Hospital, Montréal PQ, Canada.
This is a thorough and thoughtful examination of a complex area. No one test of cognitive function in the demented is adequate by itself. Different stages of the illness require different approaches. Because this book primarily concerns research study design and execution, it does not discuss the question of when to stop treatment medications clinically. This book is a milestone in describing the playing field upon which drug trials of Alzheimer's disease should be conducted. It is a testament to how all the measures used to diagnose Alzheimer's disease do not equally gauge the progression of the disease. Alzheimer's disease is not monolithic, but varies greatly from stage to stage.
This book promotes new ways of approaching this aspect of the disease.
-----------------------------------------------------------
Weighted Numerical Score: 90 - 4 Stars!
David O'Staats, (Doody's Review, 2006)
