Observations and suggestions on antidementia drug development.
Recent advances in the theoretical neurosciences have suggested a number of novel strategies that might be applied to prevent and/or retard the progression of Alzheimer disease. Whether or not these interventions will succeed cannot be determined on theoretical grounds, however; the value of each new stratagem must be evaluated in patients with Alzheimer disease. How best to conduct clinical studies of disease-modifying treatments remains a controversial subject. The author reviews and compares two clinical trial designs that may prove useful in assessing whether or not a putative treatment actually modifies the course of dementia.
Leber
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Division of Neuropharmacological Drug Products, Food and Drug Administration, Rockville, Maryland 20850, USA.
D000544:Alzheimer Disease / Q000188:drug therapy / Q000517:prevention & control*; D002986:Clinical Trials as Topic / Q000379:methods*; D004358:Drug Therapy; D006801:Humans; D012107:Research Design