This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and day 45.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Orally-Active Selective P45 MAP Kinase inhibitor
Alzheimer Research Center, VU Medical Center
Amsterdam, Netherlands
Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET
Percent change in global cortical amyloid specific PET signal (BPND)
Time frame: Baseline compared to following 12 weeks' dosing with VX-745
Number of 11C-PiB Responders
Number of patients meeting protocol pre-specified definition of response: \> 7% reduction in global cortical BPND
Time frame: Day 84
Wechsler Memory Scale (WMS) Immediate Recall Composite
WMS immediate-recall composite score consisted of the sum of the scores on Logical Memory I, Verbal Paired Associates I, and Visual Reproduction I. The composite score ranges from 0 to 136; with higher score indicating better performance.
Time frame: Baseline to Day 84
Wechsler Memory Scale (WMS) Delayed Recall Composite
WMS delayed-recall composite score at each testing sessions consisted of the sum of the scores on Logical Memory II, Verbal Paired Associates II, and Visual Reproduction II. The composite score ranges from 0 to 136; with higher scores indicating better performance.
Time frame: Change from baseline to Day 84
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