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Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02423200
First Posted: April 22, 2015
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EIP Pharma, LLC
  Purpose
This study will assess the effects of VX-745 on markers of disease in the central nervous system of patients with MCI due to AD or with mild AD. The study will also evaluate the safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the plasma and cerebrospinal fluid concentrations of VX-745 during dosing.

Condition Intervention Phase
Alzheimer's Disease Drug: VX-745 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multiple Dose Clinical Pharmacology Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745 in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) or With Mild AD

Resource links provided by NLM:


Further study details as provided by EIP Pharma, LLC:

Primary Outcome Measures:
  • Percent change from Baseline to end of treatment in cerebrospinal fluid levels of cytokines, amyloid-beta, phospho-tau, neurofilament light chain and butylcholinesterase and fludeoxyglucose positron emission tomography [ Time Frame: Baseline and days 1 and 42 of dosing with VX-745 ]

Secondary Outcome Measures:
  • Number and severity of adverse events with VX-745 in patients with MCI or AD [ Time Frame: At baseline and at each study visit during (days 1, 7, 14, 21, 28, 35 and 42) and after (day 51) dosing ]
  • Area-under-curve (AUC) of plasma drug concentrations of VX-745 [ Time Frame: On day 1 and 42 of VX-745 dosing, at 0.5, 1, 2, 3, 4, 5, 6 and 8 hours post-dose ]
  • Maximal CSF VX-745 concentration [ Time Frame: On day 1 and 42 of VX-745 dosing, 0, 3 and 6h post-dose ]

Enrollment: 16
Study Start Date: April 2015
Study Completion Date: November 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX-745 dose level 1
Active Group 1: VX-745 dose level 1 twice daily
Drug: VX-745
Orally-active P38 MAP kinase alpha-selective inhibitor
Experimental: VX-745 dose level 2
Active Group 1: VX-745 dose level 2 twice daily
Drug: VX-745
Orally-active P38 MAP kinase alpha-selective inhibitor

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 60 - 85 (inclusive)
  • Willing and able to provide informed consent
  • Clinical presentation consistent with MCI due to AD or of mild AD

    • Gradual progressive decline in memory function over >6 months
    • Amnestic presentation on neuropsychological testing with rapid forgetting (% reduction 1.5 standard deviations below the mean)
    • Clinical Dementia Rating (CDR) Sum of Box (SOB) score ≥0.5
    • Mini-Mental State Examination (MMSE) range: 20 to 30
  • Brain hypometabolism by 18F-2-fluoro-2-deoxyglucose (FDG)-PET
  • Participants may be taking medications for AD, provided that the dose of these medications has been stable for >3 months.

Exclusion Criteria:

  • Evidence of neurodegenerative disease other than AD
  • Inability for any reason to undergo MRI scans (e.g. pacemaker, vascular stent or stent graft). Patients who require sedation for screening procedures such as MRI may receive a short-acting sedative.
  • Psychiatric disorder that would compromise ability to comply with study requirements
  • History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
  • 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
  • Psychotropic drugs taken within 1 month. Anticoagulant drugs taken within 1 week.
  • 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
  • Donation of >500 mL of blood or blood products within 2 months
  • History of alcohol and/or illicit drug abuse within 6 months.
  • Infection with hepatitis A, B or C or HIV.
  • Any factor deemed by the investigator to be likely to interfere with study conduction
  Contacts and Locations
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): NCT02423200


Locations
United States, California
Parexel International
Glendale, California, United States, 91206
Sponsors and Collaborators
EIP Pharma, LLC
Investigators
Principal Investigator: Hakop Gevorkyan, MD Parexel
  More Information

Responsible Party: EIP Pharma, LLC
ClinicalTrials.gov Identifier: NCT02423200     History of Changes
Other Study ID Numbers: EIP14-745-303
First Submitted: April 3, 2015
First Posted: April 22, 2015
Last Update Posted: April 17, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders