Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab

18. februar 2020 opdateret af: Genentech, Inc.

A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

360

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
        • The Med Arts Health Rsrch Grp
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia Hospital; Division of Neurology
    • Nova Scotia
      • Halilfax, Nova Scotia, Canada, B3H 2E1
        • Capitol District Health Authority
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • JBN Medical Diagnostic Services Inc.
      • Kingston, Ontario, Canada, K7L 2V7
        • Hotel Dieu Hospital
      • London, Ontario, Canada, N6C 5J1
        • St. Joseph's HC-Parkwood Hosp
      • Ottawa, Ontario, Canada, K1N 5C8
        • Bruyère Continuing Care
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program (Neurology Research Inc.)
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Clinique Neuro Rive-Sud
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
      • Quebec City, Quebec, Canada, G1J 1Z4
        • CHAUQ Hopital Enfant-Jesus
      • Verdun, Quebec, Canada, H4H 1R3
        • McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
  • Det Forenede Kongerige
      • Bath, Det Forenede Kongerige, BA1 3NG
        • The Rice Centre; Royal United Hospital
      • Brentford, Det Forenede Kongerige, TW8 8DS
        • West London Research Unit; Brentford Lodge
      • Brighton, Det Forenede Kongerige, BN2 5BE
        • Royal Sussex County Hospital, CIRU Level 5
      • Glasgow, Det Forenede Kongerige, G20 0XA
        • Glasgow Memory Clinic
      • London, GT LON, Det Forenede Kongerige, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery; Dementia Research Center
      • Southampton, Det Forenede Kongerige, SO30 3JB
        • Moorgreen Hospital; Memory Assessment & Rsch Ctr
      • Southampton, Det Forenede Kongerige, SO16 6YD
        • Southampton General Hospital; Pharmacy
      • Swindon, Det Forenede Kongerige, SN3 6BW
        • Great Western Hosp.; Kingshill Research Ctr
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Banner Alzheimer's Institute
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic
      • Sun City, Arizona, Forenede Stater, 85351
        • Banner Sun Health Research Insitute
    • California
      • Encino, California, Forenede Stater, 91316
        • Pharmacology Research Inst
      • Fresno, California, Forenede Stater, 93720
        • Margolin Brain Institute
      • La Jolla, California, Forenede Stater, 92037
        • Univ of CA San Diego; Neurosciences Comp.Alzheimer's
      • Los Angeles, California, Forenede Stater, 90095
        • University of California Los Angeles (UCLA)
      • Los Angeles, California, Forenede Stater, 90033
        • USC School of Medicine
      • Newport Beach, California, Forenede Stater, 92660
        • Pharmacology Research Inst
      • Oxnard, California, Forenede Stater, 93030
        • Pacific Neuroscience Med Grp
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford Univ Medical Center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Medical System
      • San Diego, California, Forenede Stater, 92103
        • Pacific Research Network - PRN
      • San Francisco, California, Forenede Stater, 94117
        • Uni of California San Francisco
      • Santa Rosa, California, Forenede Stater, 95403
        • Redwood Regional Medical Group
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Yale University
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33431
        • Florida Atlantic University; College of Medicine
      • Brooksville, Florida, Forenede Stater, 34601
        • Meridien Research
      • Delray Beach, Florida, Forenede Stater, 33445
        • Brain Matters Research, Inc.
      • Miami, Florida, Forenede Stater, 33137
        • Miami Jewish Health Systems; Clinical Research
      • Naples, Florida, Forenede Stater, 34105
        • Collier Neurologic Specialists
      • Orlando, Florida, Forenede Stater, 32806
        • Bioclinica Research
      • Tampa, Florida, Forenede Stater, 33609
        • Axiom Clinical Research of Florida
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Premiere Research Institute
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • DeKalb Neurology Associates
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Alzheimer's Disease Cntr.
      • Elk Grove Village, Illinois, Forenede Stater, 60007
        • Alexian Brothers Neurosci Inst
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ School of Med
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70114
        • Louisiana Research Associates
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Hattiesburg Clinic
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63132
        • Millennium Psychiatric Associates, LLC
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Cleveland Clinic Lou Ruvo; Center for Brain Research
    • New Jersey
      • Eatontown, New Jersey, Forenede Stater, 07724
        • Memory Enhancement Center of America, Inc.
      • Mount Arlington, New Jersey, Forenede Stater, 07856
        • NeuroCognitive Institute
    • New York
      • Latham, New York, Forenede Stater, 12210
        • Empire Neurology, PC
      • Manhasset, New York, Forenede Stater, 11030
        • Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
      • Rochester, New York, Forenede Stater, 14627
        • University of Rochester Medical Center; Monroe Community Hospital
      • Rochester, New York, Forenede Stater, 14642
        • Investigational Drug Service; Univ of Rochester Medical Ctr
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607-6520
        • Raleigh Neurology Associates
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Summit Research Network Inc.
    • Pennsylvania
      • Jenkintown, Pennsylvania, Forenede Stater, 19046
        • The Clinical Trial Center, LLC
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Rhode Island Mood & Memory Research Institute
      • Providence, Rhode Island, Forenede Stater, 02906
        • Butler Hospital
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29425
        • Medical Uni of South Carolina
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
    • Vermont
      • Bennington, Vermont, Forenede Stater, 05201
        • Clinical Neuroscience Research Associates, Inc.
  • Frankrig
      • Bron, Frankrig, 69677
        • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
      • Limoges, Frankrig, 87042
        • CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
      • Nancy, Frankrig, 54035
        • Hopital Central; Neurologie
      • Nantes, Frankrig, 44093
        • Hopital Nord Laennec
      • Rouen, Frankrig, 76031
        • CHU de Rouen Hopital; Service de Neurologie
      • Strasbourg, Frankrig, 67091
        • Hôpital Civil de Strasbourg
  • Spanien
      • Albacete, Spanien, 2006
        • Complejo Hospitalario Universitario de Albacete
      • Madrid, Spanien, 28006
        • Clinica Ruber, 4 planta; Servicio de Neurologia
    • Barcelona
      • BArcelon, Barcelona, Spanien, 08034
        • Fundació ACE
      • San Cugat Del Valles, Barcelona, Spanien, 08195
        • Hospital General de Catalunya
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spanien, 20009
        • Policlinica Guipuzcoa
    • Vizcaya
      • Barakaldo, Vizcaya, Spanien, 48903
        • Hospital de Cruces; Servicio de Neurologia
  • Tyskland
      • Berlin, Tyskland, 12203
        • Univ Berlin; Klin fur Psychi & Psycho Charite
      • Günzburg, Tyskland, 89312
        • Bezirkskrankenhaus Günzburg
      • Mannheim, Tyskland, 68159
        • Zentralinstitut fuer Seelische Gesundheit
      • Munchen, Tyskland, 81377
        • Ludwig-Maximilians-Univ.
      • Munchen, Tyskland, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • Tubingen, Tyskland, 72076
        • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73 visit
  • Adequate visual and auditory acuity, in the investigator's judgment, to allow for neuropsychological testing
  • Availability of a person ("caregiver") who can provide information on activities of daily living and behavior in order to complete the study-specific assessments
  • Diagnosis of probable Alzheimer's disease according to the National Institute on Neurological and Communication Disease and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)
  • Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al. 1975)
  • For male participants with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study and for at least 8 weeks following the last dose of study drug
  • For female participants, a negative pregnancy test at screening

Exclusion Criteria:

  • Early treatment and/or study discontinuation prior to completion of the Week 73 visit of Genentech Study ABE4869g or ABE4955g
  • Early discontinuation from the treatment schedule of a prior version of Study GN28525 for safety reasons. If treatment discontinuation occurred for safety reasons, participants may not re-start dosing on extended treatment schedules offered in amendments to Study GN28525
  • Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication to MRI
  • Female participants with reproductive potential: Female participants must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months
  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the participant's ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain
  • History of severe, clinically significant central nervous system trauma
  • History or presence of clinically relevant intracranial tumor
  • Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease
  • History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
  • Evidence of malignancies (except squamous cell cancer or basal cell cancer of the skin), acute infections, renal failure that requires dialysis, or other unstable medical disease not related to Alzheimer's disease that, in the investigator's opinion, would preclude participant's participation. Cancer that is not being actively treated with anti-cancer therapy or radiotherapy as well as cancers which are considered to have low probability of recurrence are allowed
  • History or presence of atrial fibrillation that, in the investigator's judgment, poses a risk for future stroke
  • Chronic kidney disease of Stage greater than or equal to (>=) 4, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for chronic kidney disease (CKD)
  • Impaired hepatic function
  • Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [>] 1.2 times upper limit of normal [ULN])
  • Platelet count less than (<) 100,000 per microliter (mcL)
  • Presence at screening of superficial siderosis of central nervous system, more than 8 cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage
  • Presence at screening of any other significant cerebral abnormalities, including ARIA-E
  • Treatment with anticoagulation medications within 2 weeks prior to enrollment. Clopidogrel, dipyridamole, and aspirin are permitted
  • Treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates within 2 weeks prior to enrollment. All other antidepressants and atypical antipsychotics are allowed with certain restrictions as defined in the protocol
  • Chronic use of opiates, opioids, or benzodiazepines
  • Any biologic therapy within 75 weeks prior to enrollment
  • Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment
  • Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates, or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer. All other antidepressants and atypical antipsychotics are allowed. Chronic use of benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is allowed, except within 2 days prior to any neurocognitive assessment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Medicin: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Andre navne:
  • RO5490245

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Adverse Events (AEs)
Tidsramme: Up to 50 months
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Up to 50 months
Percentage of Participants by Nature of AEs
Tidsramme: Up to 50 months
A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.
Up to 50 months
Percentage of Participants by Severity of AEs
Tidsramme: Up to 50 months
AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.
Up to 50 months
Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
Tidsramme: Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.
Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
Tidsramme: Baseline, Weeks 23, 47, 71, 97, 121 and 153
Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.
Baseline, Weeks 23, 47, 71, 97, 121 and 153
Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
Tidsramme: Baseline, Weeks 23, 47, 71, 97, 121 and 153
AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.
Baseline, Weeks 23, 47, 71, 97, 121 and 153

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genentech, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. december 2012

Primær færdiggørelse (Faktiske)

8. februar 2017

Studieafslutning (Faktiske)

8. februar 2017

Datoer for studieregistrering

Først indsendt

6. november 2012

Først indsendt, der opfyldte QC-kriterier

6. november 2012

Først opslået (Skøn)

8. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GN28525
  • 2012-003242-33 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Crenezumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mongolia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner