This study will assess the effects of VX-745 on markers of disease in the central nervous system of patients with MCI due to AD or with mild AD. The study will also evaluate the safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the plasma and cerebrospinal fluid concentrations of VX-745 during dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Orally-active P38 MAP kinase alpha-selective inhibitor
Parexel International
Glendale, California, United States
Percent Change From Baseline to End of Treatment in Cerebrospinal Fluid Levels of Cytokines
Cytokines: Of nine cytokines assessed, only CSF IL-8 quantifiable at all time points. And so, only IL-8 levels are being reported herein. The analysis was exploratory and no statistical analysis was performed.
Time frame: Baseline and Day 42 of dosing with VX-745
Severe or Serious Adverse Events
Number of patients with severe or serious adverse events
Time frame: At baseline and at each study visit during (days 1, 7, 14, 21, 28, 35 and 42) and after (day 51) dosing
Maximal CSF VX-745 Concentration
Ratio fo CSF to plasma drug concentration at time matched time points. Samples taken
Time frame: All samples with quantifiable CSF drug levels were included (n=12). Eight were obtained 3-hours post-dose, either on Day 1 (n=4) or Day 42 (n=4). 3 samples were at 6-hours post-dose on Day 42; and one was at 6-hours post-dose on Day 1.
Episodic Memory Function
Total Recall in Hopkins Verbal Learning Test (HVLT). Range is 0-36, with increases in score indicating improvement in cognitive function.
Time frame: Change from baseline to Day 42
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