Abstract
Objectives: To evaluate the plasma and cerebrospinal fluid (CSF) of subjects with Alzheimer's disease (AD) to assess celecoxib pharmacokinetics (PK) and its effects on pharmacodynamic (PD) outcome measures, prostaglandin (PG) synthesis, inflammation processes, and protein markers for AD progression and cognition. Methods: This was a 4‐week, double‐blind, placebo‐controlled trial evaluating 3 dose levels of celecoxib (50, 200 and 400 mg BID), placebo, or 1 dose level of celecoxib 400 mg BID in age‐matched controls in concurrent panels of 5 subjects each. Results: 21 subjects with AD and 5 age‐matched controls were controlled. The mean concentration of celecoxib in CSF gradually increased and peaked at 4 hours post‐dose on Day 28 for all groups, and decreased to near or below the 30‐minute pre‐dose levels by 12 hours post‐dose. Mean peak celecoxib plasma concentration peaked at 2 hours post dose on Day 28 and was not dose dependent. PD analysis revealed that Prostaglandin E2 (PGE2) levels in the CSF indicat...
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