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| |  Tarenflurbil Does Not Appear to Slow Cognitive Decline in Alzheimer Disease CHICAGO -- December 15, 2009 -- Although there were promising results in a phase 2 trial, patients with mild Alzheimer disease (AD) who received tarenflurbil as part of a phase 3 trial did not have better outcomes on measures of cognitive decline or loss of activities of daily living compared with patients who received placebo. The results are published in the December 16 issue of JAMA. Robert C. Green, MD, Boston University Schools of Medicine and Public Health, Boston, Massachusetts, and colleagues conducted a large phase 3, randomised trial of tarenflurbil in patients with mild AD to determine its efficacy, safety and tolerability. The multicentre study included 1,684 participants who were randomised, of whom 1,649 were included in the analysis, and 1,046 completed the 18-month trial. Patients were randomised to receive tarenflurbil 800 mg BID or a placebo. The researchers found that tarenflurbil had no beneficial effect on the primary outcomes of cognition and activities of daily living after 18 months. There were also no significant differences on secondary outcomes, which included other AD assessment measures such as quality of life and caregiver burden. Regarding adverse events, more participants taking tarenflurbil than those taking placebo experienced dizziness, upper respiratory tract infections, and anaemia. “Our results are … a reminder that interventions affecting amyloid have not yet been shown to alter the course of AD,” the authors concluded. In an accompanying editorial, Thomas J. Montine, MD, University of Washington, and Eric B. Larson, MD, Group Health Research Institute, Seattle, Washington, comment on the findings of the 2 studies: “The null outcome for [tarenflurbil] in a phase 3 trial and the surprisingly strong association between plasma leptin and incident Alzheimer disease underscore the need to broaden the current view of potential therapeutic approaches to cognitive impairment and dementia in older individuals,” they wrote. “Research must seek a fuller understanding of the complex convergence of Alzheimer disease with vascular disease and Lewy body disease, the application of biomarkers and other surrogates to clinical trials to quantify specific pharmacologic effects, and a multimodal approach to prevention and treatment. Doing so could have profound effects on the increasing numbers of older persons and on the societies confronting the global challenge of late-life dementias in decades to come.” SOURCE: JAMA
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