The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
17
10 mg/kg, single dose administered intravenously
Placebo
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Stockholm, Sweden
Fractional Clearance rate of ABeta peptide in CSF
Time frame: 36 hours
Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion
Time frame: 36 hours
PF-04360365 concentrations and ABETA concentrations in plasma and CSF
Time frame: 36 hours
Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration
Time frame: 36 hours
Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI
Time frame: 6 months
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