Trial Designs and Outcomes in Dementia Therapeutic Research

Front Cover
CRC Press, 2005 M11 23 - 324 pages
Given the increased attention of 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. From the first steps in the early 1960s 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.

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Contents

List of Contributors
Preface
Introduction Expectations of Treatment with the Cholinesterase Inhibition Strategy
The History of Therapeutic Trials in Dementia
Treatment Hypotheses
Clinical Trial Designs and Endpoint Selection
The Use of Qualitative Research
Inclusion and Exclusion Criteria
Structural Neuroimaging Outcomes
Guidelines for Randomised Clinical Studies in Parkinsons Disease with Dementia and Dementia with Lewy Bodies
Clinical Trials for Vascular Cognitive Impairment
Clinical Trials for Primary Prevention in Dementia
Clinical Trials for Memantine
Clinical Trials for Psychotropic Agents in Alzheimers Disease
Clinical Trials for Psychosocial Interventions Aimed at Caregivers of People with Dementia
Pharmacoeconomic Outcomes

Global Assessment Measures
Cognitive Outcomes
Functional Outcomes
Behavioural Outcomes
Quality of Life Outcomes
Caregiver Burden Outcomes
Executive Dysfunction in Dementia
Ethical Considerations in the Conduct of Clinical Trials for Alzheimers Disease
Designs for Trials when there is a Standard Therapy Superiority Equivalence NonInferiority
Conclusion Lessons from Clinical Trials in Dementia
Index
Copyright

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About the author (2005)

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.

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