Overview

This trial is active, not recruiting.

Conditions alzheimer's disease, mild cognitive impairment
Treatment vx-745
Phase phase 2
Sponsor EIP Pharma, LLC
Start date April 2015
End date July 2016
Trial size 16 participants
Trial identifier NCT02423122, EIP-VX00-745-302

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Active Group 1: VX-745 40 mg twice daily
vx-745
Orally-Active Selective P45 MAP Kinase inhibitor
(Experimental)
Active Group 2: VX-745 125 mg twice daily
vx-745
Orally-Active Selective P45 MAP Kinase inhibitor

Primary Outcomes

Measure
Percent change from Baseline in amyloid plaque burden by 11C-PiB PET
time frame: Baseline compared to following 12 weeks' dosing with VX-745

Secondary Outcomes

Measure
Number of adverse events
time frame: During 12-week dosing with VX-745 and 2-week follow-up

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by EIP Pharma, LLC.