The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
402
15 mg for 6 days followed by daily dosing of 5mg
60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
Placebo
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
Time frame: 18 Month
Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).
Time frame: 18 Month
Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)
Time frame: 18 Month
Evaluate the potential dose response of PF 04494700
Time frame: 18 Month
Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints
Time frame: 18 Month
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Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Sun City, Arizona, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Martinez, California, United States
...and 52 more locations