Clinical Trial: A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745, to Evaluate the Effects of 12-Week Oral Twice-Daily Dosing on Amyloid Plaque Load as Assesse

Brief Summary: 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.

Detailed Summary:
Sponsor: EIP Pharma, LLC

Current Primary Outcome: Percent change from Baseline in amyloid plaque burden by 11C-PiB PET [ Time Frame: Baseline compared to following 12 weeks' dosing with VX-745 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of adverse events [ Time Frame: During 12-week dosing with VX-745 and 2-week follow-up ]

Adverse event incidence will be recorded and graded for severity


Original Secondary Outcome: Same as current

Information By: EIP Pharma, LLC

Dates:
Date Received: April 14, 2015
Date Started: April 2015
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017