Clinical trials in Alzheimer disease

Debate on the use of placebo controls

Claudia H. Kawas, Christopher M. Clark, Martin Farlow, David S. Knopman, Daniel Marson, John C. Morris, Leon J. Thal, Peter J. Whitehouse

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

During the past 10 years, there has been a rapidly growing number of pharmaceutical industry-sponsored drug trials for treatment of Alzheimer disease (AD) and other neurodegenerative diseases. As public awareness and concerns about AD have grown, so has interest in developing drug therapies for retarding symptom progression, delaying onset, and ultimately curing the disease. Ethical debate on the use of placebo control trials in AD research has come of age in the United States with the availability of treatments approved by the Food and Drug Administration. The experts and the public agree that more effective therapies are necessary, and new therapeutic options are being developed as rapidly as possible. The arguments on each side of the debate are provocative and important but do not provide unequivocal justification for either the abandonment or the maintenance of placebo-controlled trials in all AD research. Clinical trials differ with respect to scientific and practical goals, and these factors inherently affect the ethical priorities of each study. We present these contrasting points of view to delineate some of the issues rather than to make specific recommendations other than to urge that all clinical trials in AD should be designed with careful consideration of the ethical issues surrounding the use of placebo controls. As new and more effective treatments emerge, the ethical framework for placebo use in AD studies will require frequent re-examination. To make wise choices, patients, caregivers, physicians, and ethicists (among others) must have a voice in this continuing discussion.

Original languageEnglish
Pages (from-to)124-129
Number of pages6
JournalAlzheimer Disease and Associated Disorders
Volume13
Issue number3
StatePublished - Jul 1999

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Alzheimer Disease
Placebos
Clinical Trials
Ethicists
Therapeutics
Drug Industry
United States Food and Drug Administration
Research
Ethics
Neurodegenerative Diseases
Caregivers
Maintenance
Physicians
Drug Therapy
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Neuroscience(all)

Cite this

Kawas, C. H., Clark, C. M., Farlow, M., Knopman, D. S., Marson, D., Morris, J. C., ... Whitehouse, P. J. (1999). Clinical trials in Alzheimer disease: Debate on the use of placebo controls. Alzheimer Disease and Associated Disorders, 13(3), 124-129.

Clinical trials in Alzheimer disease : Debate on the use of placebo controls. / Kawas, Claudia H.; Clark, Christopher M.; Farlow, Martin; Knopman, David S.; Marson, Daniel; Morris, John C.; Thal, Leon J.; Whitehouse, Peter J.

In: Alzheimer Disease and Associated Disorders, Vol. 13, No. 3, 07.1999, p. 124-129.

Research output: Contribution to journalArticle

Kawas, CH, Clark, CM, Farlow, M, Knopman, DS, Marson, D, Morris, JC, Thal, LJ & Whitehouse, PJ 1999, 'Clinical trials in Alzheimer disease: Debate on the use of placebo controls', Alzheimer Disease and Associated Disorders, vol. 13, no. 3, pp. 124-129.
Kawas CH, Clark CM, Farlow M, Knopman DS, Marson D, Morris JC et al. Clinical trials in Alzheimer disease: Debate on the use of placebo controls. Alzheimer Disease and Associated Disorders. 1999 Jul;13(3):124-129.
Kawas, Claudia H. ; Clark, Christopher M. ; Farlow, Martin ; Knopman, David S. ; Marson, Daniel ; Morris, John C. ; Thal, Leon J. ; Whitehouse, Peter J. / Clinical trials in Alzheimer disease : Debate on the use of placebo controls. In: Alzheimer Disease and Associated Disorders. 1999 ; Vol. 13, No. 3. pp. 124-129.
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