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

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ClinicalTrials.gov Identifier: NCT02423122
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
EIP Pharma Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: VX-745 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-745 dose 1
Active Group 1: VX-745 40 mg twice daily
 Drug: VX-745
Orally-Active Selective P45 MAP Kinase inhibitor
Experimental: VX-745 dose 2
Active Group 2: VX-745 125 mg twice daily
 Drug: VX-745
Orally-Active Selective P45 MAP Kinase inhibitor


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423122


Locations
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Netherlands
Alzheimer Research Center, VU Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
EIP Pharma Inc
Investigators
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Principal Investigator: Philip Scheltens, MD Alheimer Research Center, VU medisch centrum
More Information
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Responsible Party: EIP Pharma Inc
ClinicalTrials.gov Identifier: NCT02423122     History of Changes
Other Study ID Numbers: EIP-VX00-745-302
First Posted: April 22, 2015    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: January 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Plaque, Amyloid
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Pathological Conditions, Anatomical