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PF-04494700, an Oral Inhibitor of Receptor for Advanced Glycation End... » Isaúde
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Alzheimer Disease and Associated Disorders
2011-07-01 00:00:00

PF-04494700, an Oral Inhibitor of Receptor for Advanced Glycation End Products (RAGE), in Alzheimer Disease

Descrição: Objective: To evaluate the safety and tolerability of PF-04494700, an oral inhibitor of receptor for advanced glycation end products, in patients with mild-to-moderate dementia of the Alzheimer type.Methods: Patients aged 50 years and older who met the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer\'s Disease and Related Disorders Association criteria for Alzheimer disease with an Mini-Mental State Examination (MMSE) score between 12 and 26 (inclusive) were randomized to 10 weeks of double-blind treatment with either a 10 mg -low dose- of PF-04494700 (after a 6-d loading dose of 30 mg/d), a 20 mg -high dose- of PF-04494700 (after a loading dose of 60 mg/d), or placebo. Safety measures included adverse events, laboratory tests, vital signs, and 12-lead electrocardiogram.Results: Twenty-seven patients received PF-04494700 30/co mg (female: 63%; mean age: 74.6 y; mean MMSE: 21.1), 28 patients received PF-04494700 60/20 mg (female: 57%; mean age: 76.6 y; mean MMSE: 21.6), and 12 patients received placebo (female: 67%; mean age: 74.1 y; mean MMSE: 19.2). A higher proportion of patients completed 10 weeks of double-blind treatment on both the -low-dose- regimen of PF-04494700 (88.9%) and the -high-dose- regimen (85.7%) than patients who were on placebo (66.7%). Discontinuation owing to adverse events and incidence of severe adverse events, respectively, were lower in the -low-dose- regimen (7.4%, 11.1%) and the -high-dose- regimen (3.6%, 10.7%) compared with placebo (25.0%, 16.7%). There were no clinically meaningful differences in vital signs, laboratory test results, or mean electrocardiogram parameters in patients treated with PF-04494700. PF-04494700 had no consistent effect on plasma levels of --amyloid, inflammatory biomarkers, or secondary cognitive outcomes.Conclusions: Ten weeks of treatment with PF-04494700 was safe and well tolerated in patients with mild-to-moderate Alzheimer disease, indicating the feasibility of a larger long-term efficacy trial.

Seção: Original Articles
Volume: 0
Autor: Chin, Alexander L.; Negash, Selamawit; Hamilton, Roy

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