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

March 28, 2014 updated by: FORUM Pharmaceuticals Inc

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

409

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Clinical Site 1
      • Bucharest, Romania
        • Clinical Site 2
      • Bucharest, Romania
        • Clinical Site 3
      • Bucharest, Romania
        • Clinical Site 4
      • Bucharest, Romania
        • Clinical Site 5
      • Iasi, Romania, 700282
      • Oradea, Romania, 410154
      • Tirgu Mures, Romania
  • Russian Federation
      • Kazan, Russian Federation, 420064
      • Moscow, Russian Federation, 115552
        • Clinical Site 1
      • Moscow, Russian Federation
        • Clinical Site 2
      • Saratov, Russian Federation, 410060
      • St Petersburg, Russian Federation, 194175
        • Clinical Site 3
      • St Petersburg, Russian Federation
        • Clinical Site 4
      • St. Petersburg, Russian Federation, 190005
        • Clinical Site 1
      • St. Petersburg, Russian Federation, 190103
        • Clinical Site 2
      • Voronezh, Russian Federation, 394052
      • Yekaterinburg, Russian Federation
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Site 1
      • Belgrade, Serbia, 11000
        • Clinical Site 2
      • Kragujevac, Serbia, 34000
      • Nis, Serbia, 18000
  • Ukraine
      • Dnipropetrovs'k, Ukraine, 490005
      • Donets'k, Ukraine, 83037
      • Kyiv, Ukraine, 04080
        • (1)
      • Kyiv, Ukraine, 04080
        • (2)
      • Odesa, Ukraine, 65006
      • Simferopol, Ukraine, 95006
      • Vinnytsya, Ukraine, 21005
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
    • California
      • Chino, California, United States, 91710
        • Catalina Research Institute
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research
      • Orange, California, United States, 92868
        • University of California, Irvine
      • Santa Rosa, California, United States, 95405
        • Radiant Research
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Research Center for Clinical Studies, Inc.
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Miami Springs, Florida, United States, 33166
        • Galiz Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Medical Institute
      • Toms River, New Jersey, United States, 08755
        • Memory Enhancement Center of NJ
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute
      • Brooklyn, New York, United States, 11214
        • Brooklyn Medical Institute
      • Elmsford, New York, United States, 10523
        • Advanced Bio Behavioral Sciences Inc.
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center at MCH
    • Ohio
      • Columbus, Ohio, United States, 31909
        • Columbus Research and Wellness Institute
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Texas
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, L.P.
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
    • Virginia
      • Williamsburg, Virginia, United States, 23185
        • The Center for Excellence in Aging and Geriatric Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EVP-6124 0.3 mg
one 0.3 mg capsule every day for 183 days
Drug: EVP-6124
Active Comparator: EVP-6124 1 mg
one 1 mg capsule every day for 183 days
Drug: EVP-6124
Active Comparator: EVP-6124 2 mg
one 2 mg capsule every day for 183 days
Drug: EVP-6124
Placebo Comparator: Placebo
Placebo every day for 183 days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Day -7, Baseline, 4, 12, 18, 23 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale-Cognitive subscale-11
Time Frame: 4, 12, 18, 23 Weeks
4, 12, 18, 23 Weeks
Controlled Oral Word Association Test
Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Day -7, Baseline, 4, 12, 18, 23 Weeks
Category Fluency Test
Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Day -7, Baseline, 4, 12, 18, 23 Weeks
Clinical Dementia Rating Scale Sum of Boxes
Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Day -7, Baseline, 4, 12, 18, 23 Weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Time Frame: Baseline, 4, 12, 18, 23 Weeks
Baseline, 4, 12, 18, 23 Weeks
Neuropsychiatric Inventory
Time Frame: Baseline, 12, 23 Weeks
Baseline, 12, 23 Weeks
Mini-Mental State Exam
Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Day -7, Baseline, 4, 12, 18, 23 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FORUM Pharmaceuticals Inc

Collaborators

INC Research Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVP-6124-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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