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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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