Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025

May 2, 2016 updated by: FORUM Pharmaceuticals Inc

A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects With Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Phase 3

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

  • Australia
    • Victoria
      • Geelong, Victoria, Australia
  • Belgium
      • Leuven, Belgium
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Chatham, Ontario, Canada
      • Toronto, Ontario, Canada
  • Czech Republic
      • Praha, Czech Republic
      • Rychnov nad Kneznou, Czech Republic
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of
  • Netherlands
      • Amsterdam, Netherlands
  • Poland
      • Bialystok, Poland
      • Warszawa, Poland
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa
      • Pretoria, Gauteng, South Africa
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa
    • Western Cape
      • Bellville, Western Cape, South Africa
      • George, Western Cape, South Africa
      • Somerset West, Western Cape, South Africa
  • Spain
      • Burgos, Spain
      • Madrid, Spain
      • Salamanca, Spain
    • Barcelona
      • Terrassa, Barcelona, Spain
  • United Kingdom
      • Glasgow, United Kingdom
      • Isleworth, United Kingdom
      • Northampton, United Kingdom
      • Penarth, United Kingdom
      • Southampton, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Costa Mesa, California, United States
      • Culver City, California, United States
      • Encino, California, United States
      • Glendale, California, United States
      • Long Beach, California, United States
      • Los Alamitos, California, United States
      • Orange, California, United States
      • Redding, California, United States
      • San Diego, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
      • Norwich, Connecticut, United States
    • Florida
      • Atlantis, Florida, United States
      • Brooksville, Florida, United States
      • Delray Beach, Florida, United States
      • Fort Myers, Florida, United States
      • Hallandale Beach, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • Leesburg, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Sunrise, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
    • Illinois
      • Park Ridge, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
    • Massachusetts
      • Newton, Massachusetts, United States
      • Plymouth, Massachusetts, United States
    • Mississippi
      • Flowood, Mississippi, United States
      • Hattiesburg, Mississippi, United States
    • Missouri
      • Creve Coeur, Missouri, United States
    • New Jersey
      • Princeton, New Jersey, United States
      • Springfield, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Brooklyn, New York, United States
      • Cedarhurst, New York, United States
      • Latham, New York, United States
      • Staten Island, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Norristown, Pennsylvania, United States
      • Plains, Pennsylvania, United States
    • Rhode Island
      • East Providence, Rhode Island, United States
    • Texas
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Bennington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Williamsburg, Virginia, United States
    • Washington
      • Richland, Washington, United States

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025
  • Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures
  • Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
  • No clinically significant change in the judgment of the investigator in the subject's medical status during study EVP-6124-024 or EVP-6124-025
  • In the judgment of the investigator, extension treatment is in the best interest of the subject
  • Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method])
  • Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible

Exclusion Criteria:

  • Significant risk of suicidal or violent behavior in the judgment of the investigator
  • Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
  • Any condition that would make the subject in the judgment of the investigator unsuitable for the study
  • Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study

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
Experimental: EVP-6124, low dose
low dose, Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Experimental: EVP-6124, high dose
high dose, Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimer's disease who complete study EVP-6124-024 or EVP-6124-025
Time Frame: Baseline to Day 182 or Early Termination
Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, physical examination, concomitant medications, C-SSRS, and GDS.
Baseline to Day 182 or Early Termination

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Caregiver perceived burden using the Zarit Burden Interview (ZBI)
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination

Collaborators and Investigators

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

Sponsor

FORUM Pharmaceuticals Inc

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

June 1, 2014

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVP-6124-026
  • 2013-002654-75 (EudraCT Number)

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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