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Alzheimer's DiseasePhase 3NCT02004392

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

A Phase 3 study testing EVP-6124 in people with Alzheimer's Disease and Dementia, run by FORUM Pharmaceuticals Inc at 86 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease, Dementia
What is being tested?
EVP-6124
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
348 participants
Where
86 sitesin 12 countries
Study dates
Jun 2014to Aug 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

United States56 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlantis, Florida

  • Study site

    Bangor, Maine

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bennington, Vermont

  • Study site

    Brooklyn, New York

  • Study site

    Brooksville, Florida

  • Study site

    Cedarhurst, New York

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Columbus, Georgia

  • Study site

    Costa Mesa, California

  • Study site

    Creve Coeur, Missouri

  • Study site

    Culver City, California

  • Study site

    Delray Beach, Florida

  • Study site

    East Providence, Rhode Island

  • Study site

    Encino, California

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Myers, Florida

  • Study site

    Glendale, California

  • Study site

    Hallandale, Florida

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Hialeah, Florida

  • Study site

    Jacksonville, Florida

  • Study site

    Latham, New York

  • Study site

    Leesburg, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Alamitos, California

  • Study site

    Miami, Florida

  • Study site

    New Haven, Connecticut

  • Study site

    Newton, Massachusetts

  • Study site

    Norristown, Pennsylvania

  • Study site

    Norwich, Connecticut

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Park Ridge, Illinois

  • Study site

    Phoenix, Arizona

  • Study site

    Plains, Pennsylvania

  • Study site

    Plymouth, Massachusetts

  • Study site

    Portland, Oregon

  • Study site

    Princeton, New Jersey

  • Study site

    Redding, California

  • Study site

    Richland, Washington

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Springfield, New Jersey

  • Study site

    Staten Island, New York

  • Study site

    Sunrise, Florida

  • Study site

    Tucson, Arizona

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita, Kansas

  • Study site

    Williamsburg, Virginia

  • Study site

    Wilmington, North Carolina

Other trials in United States

South Africa6 sites

  • Study site

    Bellville, Western Cape

  • Study site

    Durban, KwaZulu-Natal

  • Study site

    George, Western Cape

  • Study site

    Johannesburg, Gauteng

  • Study site

    Pretoria, Gauteng

  • Study site

    Somerset West, Western Cape

Other trials in South Africa

United Kingdom5 sites

  • Study site

    Glasgow

  • Study site

    Isleworth

  • Study site

    Northampton

  • Study site

    Penarth

  • Study site

    Southampton

Other trials in United Kingdom

Canada4 sites

  • Study site

    Chatham, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Kelowna, British Columbia

  • Study site

    Toronto, Ontario

Other trials in Canada

Spain4 sites

  • Study site

    Burgos

  • Study site

    Madrid

  • Study site

    Salamanca

  • Study site

    Terrassa, Barcelona

Other trials in Spain

South Korea3 sites

  • Study site

    Busan

  • Study site

    Incheon

  • Study site

    Seoul

Other trials in South Korea

Czechia2 sites

  • Study site

    Prague

  • Study site

    Rychnov nad Kněžnou

Other trials in Czechia

Poland2 sites

  • Study site

    Bialystok

  • Study site

    Warsaw

Other trials in Poland

Australia1 site

  • Study site

    Geelong, Victoria

Other trials in Australia

Belgium1 site

  • Study site

    Leuven

Other trials in Belgium

Italy1 site

  • Study site

    Milan, Lombardy

Other trials in Italy

Netherlands1 site

  • Study site

    Amsterdam

Other trials in Netherlands

About this study

Official title: 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.

Being tested
EVP-6124
Keywords
Alzheimer's disease, Cognition, Alpha-7 nAChR
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVP-6124Drug

Study groups in NCT02004392
Study groupRoleWhat they receive
EVP-6124, low doseExperimentallow dose, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: EVP-6124
EVP-6124, high doseExperimentalhigh dose, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: EVP-6124

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, physical examination, concomitant medications, C-SSRS, and GDS.

    Measured: Baseline to Day 182 or Early Termination

Secondary outcomes (5)

  1. Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)

    Measured: Baseline to Day 182 or Early Termination

  2. Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)

    Measured: Baseline to Day 182 or Early Termination

  3. Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)

    Measured: Baseline to Day 182 or Early Termination

  4. Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)

    Measured: Baseline to Day 182 or Early Termination

  5. Caregiver perceived burden using the Zarit Burden Interview (ZBI)

    Measured: Baseline to Day 182 or Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Why it stopped: Study has been suspended due to clinical hold.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004392
Sponsor's protocol ID
EVP-6124-026
Other IDs
2013-002654-75
Status last verified
Sep 2015
First submitted
27 Nov 2013
Last updated
3 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EVP-6124 in people with Alzheimer's Disease and Dementia, run by FORUM Pharmaceuticals Inc at 86 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, South Africa, United Kingdom, Canada, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study has been suspended due to clinical hold.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.

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