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

2. mai 2016 oppdatert av: FORUM Pharmaceuticals Inc

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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

474

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia
    • Victoria
      • Geelong, Victoria, Australia
      • West Heidelberg, Victoria, Australia
  • Belgia
      • Brussels, Belgia
      • Leuven, Belgia
      • St. Truiden, Belgia
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
    • Ontario
      • Chatham, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Gatineau, Quebec, Canada
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater
      • Tucson, Arizona, Forente stater
    • California
      • Costa Mesa, California, Forente stater
      • Encino, California, Forente stater
      • Glendale, California, Forente stater
      • Long Beach, California, Forente stater
      • Redding, California, Forente stater
      • San Diego, California, Forente stater
    • Florida
      • Atlantis, Florida, Forente stater
      • Brooksville, Florida, Forente stater
      • Delray Beach, Florida, Forente stater
      • Fort Myers, Florida, Forente stater
      • Lake Worth, Florida, Forente stater
      • Miami, Florida, Forente stater
      • Orlando, Florida, Forente stater
      • St. Petersburg, Florida, Forente stater
      • Weston, Florida, Forente stater
    • Georgia
      • Columbus, Georgia, Forente stater
      • Douglasville, Georgia, Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater
      • Park Ridge, Illinois, Forente stater
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater
    • Maine
      • Bangor, Maine, Forente stater
    • Massachusetts
      • Chestnut Hill, Massachusetts, Forente stater
      • Plymouth, Massachusetts, Forente stater
    • Mississippi
      • Flowood, Mississippi, Forente stater
    • Missouri
      • Creve Coeur, Missouri, Forente stater
    • New Jersey
      • Princeton, New Jersey, Forente stater
      • Springfield, New Jersey, Forente stater
    • New York
      • Brooklyn, New York, Forente stater
      • Latham, New York, Forente stater
      • New York, New York, Forente stater
      • Staten Island, New York, Forente stater
    • North Carolina
      • Wilmington, North Carolina, Forente stater
    • Ohio
      • Columbus, Ohio, Forente stater
    • Oregon
      • Portland, Oregon, Forente stater
    • Pennsylvania
      • Norristown, Pennsylvania, Forente stater
      • Philadelphia, Pennsylvania, Forente stater
    • Texas
      • San Antonio, Texas, Forente stater
      • Wichita Falls, Texas, Forente stater
    • Utah
      • Murray, Utah, Forente stater
      • Salt Lake City, Utah, Forente stater
    • Vermont
      • Bennington, Vermont, Forente stater
    • Virginia
      • Williamsburg, Virginia, Forente stater
  • Frankrike
      • Nice, Frankrike
      • Paris, Frankrike
      • Rouen, Frankrike
      • Toulouse cedex 9, Frankrike
  • Italia
      • Brescia, Italia
      • Milano, Italia
  • Korea, Republikken
      • Busan, Korea, Republikken
      • Seoul, Korea, Republikken
    • Gyenggi-go
      • Seongnam-si, Gyenggi-go, Korea, Republikken
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
  • Polen
      • Bialystok, Polen
      • Bydgoszcz, Polen
      • Poznan, Polen
      • Warszawa, Polen
  • Spania
      • Barcelona, Spania
      • Burgos, Spania
      • Madrid, Spania
    • Altcante
      • Elche, Altcante, Spania
    • Barcelona
      • Terrassa, Barcelona, Spania
  • Sør-Afrika
      • Bellville, Sør-Afrika
      • Johannesburg, Sør-Afrika
      • Pretoria, Sør-Afrika
      • Somerset West, Sør-Afrika
  • Tyskland
      • Achim, Tyskland
      • Köln, Tyskland
      • Munchen, Tyskland
      • Nurnberg, Tyskland

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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)
  • 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)

Exclusion Criteria:

  • 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
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Eksperimentell: EVP-6124, lav dose
lav dose, tablett, én gang daglig, dag 1 til og med dag 182
Legemiddel: Legemiddel: EVP-6124
Eksperimentell: Eksperimentell: EVP-6124, høy dose
høy dose, tablett, én gang daglig, dag 1 til og med dag 182
Legemiddel: Legemiddel: EVP-6124
Placebo komparator: EVP-6124 Placebo
Placebo, Tablet, Once Daily, Day 1 through Day 182
Legemiddel: Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i Alzheimers sykdomsvurdering skala-kognitiv underskala 13-element (ADAS-Cog-13) til dag 182
Tidsramme: Grunnlinje til dag 182 eller tidlig avslutning
Grunnlinje til dag 182 eller tidlig avslutning
Endring fra baseline i Clinical Dementia Rating Sum of the Boxes (CDR-SB) til dag 182
Tidsramme: Grunnlinje til dag 182 eller tidlig avslutning
Grunnlinje til dag 182 eller tidlig avslutning
Sikkerhet og toleranse for EVP-6124 eller placebo hos pasienter med AD
Tidsramme: Grunnlinje til dag 182 eller ET
Alle uønskede opplevelser spontant rapportert av forsøksperson og/eller observert av en etterforsker og gjentatt klinisk evaluering av fysisk undersøkelse, vitale tegn, 12-avlednings EKG (elektrokardiogram), ambulerende EKG og laboratorietester (hematologi/blodkjemi/urinalyse)
Grunnlinje til dag 182 eller ET

Sekundære resultatmål

Resultatmål
Tidsramme
Endring fra baseline i dagliglivets aktiviteter ved å bruke funksjonshemmingsvurderingen for demens (DAD)
Tidsramme: Grunnlinje til dag 182 eller tidlig avslutning
Grunnlinje til dag 182 eller tidlig avslutning
Endring fra baseline i psykiatriske og atferdsmessige symptomer ved å bruke Nevropsykiatrisk inventar (NPI)
Tidsramme: Grunnlinje til dag 182 eller tidlig avslutning
Grunnlinje til dag 182 eller tidlig avslutning
Endring fra baseline i Mini-Mental State Examination (MMSE)
Tidsramme: Grunnlinje til dag 182 eller tidlig avslutning
Grunnlinje til dag 182 eller tidlig avslutning
Endring fra baseline i Controlled Oral Word Association Test (COWAT)
Tidsramme: Grunnlinje til dag 182 eller tidlig avslutning
Grunnlinje til dag 182 eller tidlig avslutning

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

FORUM Pharmaceuticals Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2013

Primær fullføring (Forventet)

1. januar 2017

Studiet fullført (Forventet)

1. januar 2017

Datoer for studieregistrering

Først innsendt

21. oktober 2013

Først innsendt som oppfylte QC-kriteriene

24. oktober 2013

Først lagt ut (Anslag)

25. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2016

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EVP-6124-024
  • 2013-002618-10 (EudraCT-nummer)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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