Alzheimer's Disease Drug Has No Beneficial Effect

According to a large phase 3, randomized trial, patients with mild Alzheimer disease who received the drug tarenflurbil did not have better outcomes on measures of cognitive decline or loss of activities of daily living compared to patients who received placebo.

A leading theory on the pathophysiology of Alzheimer disease is the overproduction of amyloid-ß (Aß; a peptide of certain amino acids that appear to be the main constituent of amyloid plaques in the brains of patients with Alzheimer disease), particularly 42 amino acid peptide Aß42. "Tarenflurbil, a selective Aß42-lowering agent, demonstrated encouraging results on cognitive and functional outcomes among mildly affected patients in an earlier phase 2 trial," the authors write.

The researchers conducted a large phase 3, randomized trial of tarenflurbil for patients with mild Alzheimer disease to determine its efficacy, safety and tolerability. The study, conducted at 133 trial sites in the United States, included 1,684 participants who were randomized, of whom 1,649 were included in the analysis, and 1,046 completed the 18-month trial. Patients were randomized to tarenflurbil, 800 mg, or placebo, administered twice a day.

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 Alzheimer disease 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 anemia.

"Our results are a reminder that interventions affecting amyloid have not yet been shown to alter the course of Alzheimer disease," the authors conclude.

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References:
1. Robert C. Green, et al. Effect of Tarenflurbil on Cognitive Decline and Activities of Daily Living in Patients With Mild Alzheimer Disease: A Randomized Controlled Trial. JAMA, December 16, 2009; 302: 2557 - 2564.