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Alzheimer's DiseasePhase 3NCT01969123

Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease

A Phase 3 study testing Drug: EVP-6124 in people with Alzheimer's Disease and Dementia, run by FORUM Pharmaceuticals Inc at 82 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

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor. 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?
Drug: EVP-6124
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
474 participants
Where
82 sitesin 12 countries
Study dates
Oct 2013to Jan 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

  • Ages ≥55 and ≤85 years
  • Informed consent form (ICF) signed by the subject or legally acceptable representative before any study-specific procedures for the subject are performed and an ICF signed by the support person/caregiver before any study-specific procedures for the support person/caregiver are performed
  • Clinical diagnosis of dementia due to probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer's Disease Association
  • Clinical decline within 12 months before screening and onset of symptoms at least 12 months or longer before screening, which may include any documented cognition, functional, or other objective assessment or the clinical judgment of the investigator or the subject's referring physician that the subject has experienced a clinical decline within the last 12 months
  • Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12 months before screening, with findings consistent with the diagnosis of dementia due to AD without any other clinically significant comorbid pathologies. If an MRI or CT scan is unavailable or occurred greater than 12 months before screening, this assessment should be completed and the findings confirmed before the subject enters the run-in period (Day -14) (copy of the report will be available at the study site)
  • Mini-Mental State Examination (MMSE) score ≥14 and ≤24 at screening and confirmed on Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day 1/baseline)
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  • Clinical Dementia Rating Global score (CDR-GS) ≥1 (at least mild dementia) at screening and confirmed on Day 1 prior to randomization
  • Modified Hachinski Ischemic Scale (mHIS) score ≤4 at screening
  • 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
  • Subject living at home, senior residential setting, or an institutional setting without the need for continuous (ie, 24-hour) nursing care
  • General health status acceptable for participation in a 26-week study
  • Fluency (oral and written) in the language in which the standardized tests will be administered
  • Receiving a stable dose of an acetylcholinesterase inhibitor (AChEI) (donepezil, rivastigmine or galantamine) for at least 3 months (90 days) before screening and with continuous dosing for at least 6 months OR not presently receiving an AChEI (at least 30 days before screening), but with a history of previous AChEI treatment (subjects receiving donepezil 23 mg currently or within 3 months before screening are ineligible)

Who cannot join

  • Exposure to an experimental drug, experimental biologic or experimental medical device within 2 months (60 days) before screening
  • Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening
  • Inability to swallow a tablet
  • In the judgment of the investigator, inability of the subject or the support person/caregiver to complete a 26-week study
  • Inability to be ≥75% compliant with single-blind study drug
  • Inability to adequately cooperate or complete the cognitive testing procedures or any study assessment
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  • Residence in a skilled nursing facility
  • Untreated vitamin B12 or folate deficiency (if treated, must be stably treated for at least 6 months before screening)
  • Clinically significant (in the judgment of the investigator) abnormal serum electrolytes (sodium, potassium, magnesium) after repeat testing
  • Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating hormone level and thyroid supplementation dose must be stable for at least 6 months before screening)
  • Insufficiently controlled diabetes mellitus (in the judgment of the investigator) or requiring insulin
  • Renal insufficiency (serum creatinine >2.0 mg/dL)
  • Malignant tumor within 3 years before screening (except squamous and basal cell carcinoma or cervical carcinoma in situ or localized prostate cancer)
  • Female subjects who are pregnant, nursing, or planning to become pregnant during the study
  • Unstable medical condition that is clinically significant in the judgment of the investigator
  • Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit of normal
  • History of myocardial infarction or unstable angina within 6 months before screening
  • History of more than 1 myocardial infarction within 5 years before screening
  • Clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (subjects with a pacemaker are acceptable)
  • Symptomatic hypotension or hypertension (supine diastolic blood pressure >95 mmHg) (in the judgment of the investigator)
  • Clinically significant abnormality on screening or baseline electrocardiogram (ECG), including but not necessarily limited to a confirmed corrected QT interval (QTc) value ≥450 msec for males or ≥470 msec for females. In subjects with a QRS value >120msec, those with a QTc value <500 msec may be eligible following discussion with the Medical Monitor.
  • Stroke within 18 months before screening, or history of a stroke concomitant with onset of dementia
  • History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI
  • Head trauma with clinically significant (in the judgment of the investigator) loss of consciousness within 12 months before screening or concurrent with the onset of dementia
  • Onset of dementia secondary (in the judgment of the investigator) to cardiac arrest, surgery with general anesthesia, or resuscitation
  • Specific degenerative central nervous system (CNS) disease diagnosis other than AD (eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Fronto-Temporal Dementia, Parkinson's disease)
  • Subjects with no history of prior treatment with an AChEI (donepezil, rivastigmine, or galantamine)
  • Memantine currently or within 30 days before screening
  • Antipsychotics; low doses (in the judgment of the investigator, except clozapine) are allowed only if given for sleep disturbances, agitation and/or aggression, and only if the subject has received a stable dose for at least 3 months before screening (but not within 8 hours before any cognitive test)
  • Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants are allowed only if the subject has received a stable dose for at least 3 months before screening
  • Antiepileptic medications if taken for control of seizures
  • Chronic intake of opioid-containing analgesics
  • Sedating H1 antihistamines
  • Nicotine therapy (including the patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening
  • Clinically significant urine drug screen or serum alcohol test result in the judgment of the investigator
  • History of ischemic colitis or ischemic enterocolitis

Trial locations and contacts

82 sites in 12 countries.

82 sites in 12 countries

United States44 sites

  • 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

    Chestnut Hill, Massachusetts

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Costa Mesa, California

  • Study site

    Creve Coeur, Missouri

  • Study site

    Delray Beach, Florida

  • Study site

    Douglasville, Georgia

  • Study site

    Encino, California

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Myers, Florida

  • Study site

    Glendale, California

  • Study site

    Lake Worth, Florida

  • Study site

    Latham, New York

  • Study site

    Long Beach, California

  • Study site

    Miami, Florida

  • Study site

    Murray, Utah

  • Study site

    New York, New York

  • Study site

    Norristown, Pennsylvania

  • Study site

    Orlando, Florida

  • Study site

    Park Ridge, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Plymouth, Massachusetts

  • Study site

    Portland, Oregon

  • Study site

    Princeton, New Jersey

  • Study site

    Redding, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Springfield, New Jersey

  • Study site

    St. Petersburg, Florida

  • Study site

    Staten Island, New York

  • Study site

    Tucson, Arizona

  • Study site

    Weston, Florida

  • Study site

    Wichita Falls, Texas

  • Study site

    Williamsburg, Virginia

  • Study site

    Wilmington, North Carolina

Other trials in United States

Spain5 sites

  • Study site

    Barcelona, Barcelona

  • Study site

    Burgos

  • Study site

    Elche, Altcante

  • Study site

    Madrid, Madrid

  • Study site

    Terrassa, Barcelona

Other trials in Spain

Canada4 sites

  • Study site

    Chatham, Ontario

  • Study site

    Gatineau, Quebec

  • Study site

    Kelowna, British Columbia

  • Study site

    Toronto, Ontario

Other trials in Canada

France4 sites

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Rouen

  • Study site

    Toulouse

Other trials in France

Germany4 sites

  • Study site

    Achim

  • Study site

    Cologne

  • Study site

    München

  • Study site

    Nuremberg

Other trials in Germany

Poland4 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Poznan

  • Study site

    Warsaw

Other trials in Poland

South Africa4 sites

  • Study site

    Bellville

  • Study site

    Johannesburg

  • Study site

    Pretoria

  • Study site

    Somerset West

Other trials in South Africa

Australia3 sites

  • Study site

    Geelong, Victoria

  • Study site

    Hornsby, New South Wales

  • Study site

    West Heidelberg, Victoria

Other trials in Australia

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Leuven

  • Study site

    Saint Truiden

Other trials in Belgium

South Korea3 sites

  • Study site

    Busan

  • Study site

    Seongnam-si, Gyenggi-go

  • Study site

    Seoul

Other trials in South Korea

Italy2 sites

  • Study site

    Brescia, Brescia

  • Study site

    Milan, Milano

Other trials in Italy

Mexico2 sites

  • Study site

    Guadalajara, Jalisco

  • Study site

    Monterrey, Nuevo León

Other trials in Mexico

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

Being tested
Drug: EVP-6124, Placebo
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.

  • Drug: EVP-6124Drug

  • PlaceboDrug

Study groups in NCT01969123
Study groupRoleWhat they receive
Experimental: EVP-6124, low doseExperimentallow dose, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: Drug: EVP-6124
Experimental: EVP-6124, high doseExperimentalhigh dose, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: Drug: EVP-6124
EVP-6124 PlaceboPlacebo comparatorPlacebo, Tablet, Once Daily, Day 1 through Day 182
Receives: Drug: Placebo

What is being measured

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

  1. Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog-13) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  2. Change from Baseline in the Clinical Dementia Rating Sum of the Boxes (CDR-SB) to Day 182

    Measured: Baseline to Day 182 or Early Termination

  3. Safety and tolerability of EVP-6124 or Placebo in Subjects with AD

    All adverse experiences spontaneously reported by subject and/or observed by an investigator and repeated clinical evaluation of physical exam, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG and laboratory tests (hematology/blood chemistry/urinalysis)

    Measured: Baseline to Day 182 or ET

Secondary outcomes (4)

  1. Change from Baseline in activities of daily living using the Disability Assessment for Dementia (DAD)

    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 the Mini-Mental State Examination (MMSE)

    Measured: Baseline to Day 182 or Early Termination

  4. Change from Baseline in the Controlled Oral Word Association Test (COWAT)

    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 posted25 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 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
474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969123
Sponsor's protocol ID
EVP-6124-024
Other IDs
2013-002618-10
Status last verified
Sep 2015
First submitted
21 Oct 2013
Last updated
3 May 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug: EVP-6124 in people with Alzheimer's Disease and Dementia, run by FORUM Pharmaceuticals Inc at 82 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 14 inclusion and 36 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 82 sites in United States, Spain, Canada, France, Germany 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. Some participants in this study may receive a placebo. 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?

Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog-13) to Day 182 (time frame: Baseline to Day 182 or Early Termination). The study lists 3 primary outcomes in all. 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 NCT01969123.

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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Clinical Trial NCT01969123 | AzTrials