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Completed

NCT Number: NCT02423122

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alzheimer Research Center, VU Medical Center

Amsterdam, 1081 HV, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-745

Drug

Orally-Active Selective P45 MAP Kinase inhibitor

Primary outcomes

  1. Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET

    Time frame: Baseline compared to following 12 weeks' dosing with VX-745

    Percent change in global cortical amyloid specific PET signal (BPND)

  2. Number of 11C-PiB Responders

    Time frame: Day 84

    Number of patients meeting protocol pre-specified definition of response: > 7% reduction in global cortical BPND

Secondary outcomes

  1. Wechsler Memory Scale (WMS) Immediate Recall Composite

    Time frame: Baseline to Day 84

    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.

  2. Wechsler Memory Scale (WMS) Delayed Recall Composite

    Time frame: Change from baseline to Day 84

    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.

Sponsors and collaborators

Lead sponsor

EIP Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2015
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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