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PF-04494700, an oral inhibitor of receptor for advanced glycation end products (RAGE), in Alzheimer disease


Sabbagh, Marwan N., Agro, Albert, Bell, Joanne, Aisen, Paul S, Schweizer, Edward, Galasko, Douglas


Alzheimer Disease And Associated Disorders, Volume: 25, No.: 3, Pages.: 206-212

Year of Publication



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 β-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.;

Bibtex Citation

@article{Sabbagh_2011, doi = {10.1097/wad.0b013e318204b550}, url = {}, year = 2011, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {25}, number = {3}, pages = {206--212}, author = {Marwan N. Sabbagh and Albert Agro and Joanne Bell and Paul S. Aisen and Edward Schweizer and Douglas Galasko}, title = {{PF}-04494700, an Oral Inhibitor of Receptor for Advanced Glycation End Products ({RAGE}), in Alzheimer Disease}, journal = {Alzheimer Disease {&} Associated Disorders} }


administration oral, advanced, adverse, aged, alzheimer disease, an, antagonists inhibitors, double-blind method, drug therapy, end, events, female, for, glycation, humans, inhibitor, male, of, oral, products, receptor, receptors immunologic

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions