Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer’s Disease

Brief Summary

Official Title: “A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer’s Disease”

This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2011

Detailed Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.

Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.

Interventions Used in this Clinical Trial

  • Drug: EVP-6124
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: EVP-6124 0.3 mg
    • one 0.3 mg capsule every day for 183 days
  • Active Comparator: EVP-6124 1 mg
    • one 1 mg capsule every day for 183 days
  • Active Comparator: EVP-6124 2 mg
    • one 2 mg capsule every day for 183 days
  • Placebo Comparator: Placebo
    • Placebo every day for 183 days

Outcome Measures for this Clinical Trial

Primary Measures

  • Alzheimer’s Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
    • Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
      Safety Issue?: No

Secondary Measures

  • Alzheimer’s Disease Assessment Scale-Cognitive subscale-11
    • Time Frame: 4, 12, 18, 23 Weeks
      Safety Issue?: No
  • Controlled Oral Word Association Test
    • Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
      Safety Issue?: No
  • Category Fluency Test
    • Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
      Safety Issue?: No
  • Clinical Dementia Rating Scale Sum of Boxes
    • Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
      Safety Issue?: No
  • Alzheimer’s Disease Cooperative Study-Activities of Daily Living
    • Time Frame: Baseline, 4, 12, 18, 23 Weeks
      Safety Issue?: No
  • Neuropsychiatric Inventory
    • Time Frame: Baseline, 12, 23 Weeks
      Safety Issue?: No
  • Mini-Mental State Exam
    • Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Subjects with Probable Alzheimer's disease
  • Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
  • Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
  • Female subjects are ≥1 year post-menopausal or are surgically sterile
  • Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
  • Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
  • General health status acceptable for participation in a 24 week clinical trial be administered

Exclusion Criteria

General

  • Participation in another therapeutic clinical trial within 30 days before Baseline
  • Prior participation in an amyloid vaccination clinical study
  • Inability to swallow capsules
  • Likely inability to complete 24 week study
  • Inability to be ≥75% compliant with single-blind placebo run-in medication
  • Inability to adequately perform cognitive tests
  • History of significant cardiovascular disease
  • Major depression
  • Psychosis
  • History of stroke within 18 months of screening
  • Head trauma
  • Inability to perform any screening or baseline evaluations

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • FORUM Pharmaceuticals Inc
  • Collaborator
    • INC Research Limited
  • Provider of Information About this Clinical Study
    • Sponsor

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01073228