A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)
This trial is active, not recruiting.
|Conditions||alzheimer's disease, mild cognitive impairment|
|Sponsor||EIP Pharma, LLC|
|Start date||April 2015|
|End date||July 2016|
|Trial size||16 participants|
|Trial identifier||NCT02423122, EIP-VX00-745-302|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Active Group 1: VX-745 40 mg twice daily
Active Group 2: VX-745 125 mg twice daily
Percent change from Baseline in amyloid plaque burden by 11C-PiB PET
time frame: Baseline compared to following 12 weeks' dosing with VX-745
Number of adverse events
time frame: During 12-week dosing with VX-745 and 2-week follow-up
Male or female participants from 60 years up to 85 years old.
Inclusion Criteria: - Willing and able to provide informed consent - Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD - MMSE range: 20 to 28 - Evidence of amyloid pathology by amyloid PET scan - Participants may be taking medications for AD, provided that the dose of these medications has been stable for >3 months - Proficiency in Dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests - Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments. Exclusion Criteria: - Evidence of neurodegenerative disease other than AD - Inability for any reason to undergo PET and fMRI scans (including notably: history of allergic reaction of any severity to 11C-PiB injection; pacemaker, vascular stent or stent graft) - Psychiatric disorder that would compromise ability to comply with study requirements - Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy - Recent (<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition - Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study - Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements - Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy - Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial - Any factor deemed by the investigator to be likely to interfere with study conduction
|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 Assessed by Quantitative Dynamic 11C-PiB Positive Emission Tomography (PET) Amyloid Scanning|
|Principal investigator||Philip Scheltens, MD|
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