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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

360

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Arzneimittel: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Andere Namen:
  • RO5490245

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Adverse Events (AEs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Genentech, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. Dezember 2012

Primärer Abschluss (Tatsächlich)

8. Februar 2017

Studienabschluss (Tatsächlich)

8. Februar 2017

Studienanmeldedaten

Zuerst eingereicht

6. November 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. November 2012

Zuerst gepostet (Schätzen)

8. November 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Februar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Februar 2020

Zuletzt verifiziert

1. Februar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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