A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
30 mg loading dose for 6 days, followed by 10 mg daily
60 mg loading dose for 6 days, followed by 20 mg daily
Matching placebo.
Pfizer Investigational Site
Sun City, Arizona, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
San Diego, California, United States
Safety Measures include Adverse Events
Time frame: Every Visit
Laboratory Tests
Time frame: Every Office Visit
12-Lead Electrocardiogram
Time frame: Every Office Visit
24-Hour 12-Lead Serial ECGs
Time frame: Baseline, Study End
Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Time frame: Baseline, Visit 5, Study End
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Time frame: Screening Visit, Baseline, Study End
Pharmacokinetic Profile
Time frame: Baseline and Every Office Visit
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Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Hallandale, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Largo, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
...and 2 more locations