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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 febbraio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

360

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Francia
      • Bron, Francia, 69677
        • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
      • Limoges, Francia, 87042
        • CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
      • Nancy, Francia, 54035
        • Hopital Central; Neurologie
      • Nantes, Francia, 44093
        • Hopital Nord Laennec
      • Rouen, Francia, 76031
        • CHU de Rouen Hopital; Service de Neurologie
      • Strasbourg, Francia, 67091
        • Hôpital Civil de Strasbourg
  • Germania
      • Berlin, Germania, 12203
        • Univ Berlin; Klin fur Psychi & Psycho Charite
      • Günzburg, Germania, 89312
        • Bezirkskrankenhaus Günzburg
      • Mannheim, Germania, 68159
        • Zentralinstitut fuer Seelische Gesundheit
      • Munchen, Germania, 81377
        • Ludwig-Maximilians-Univ.
      • Munchen, Germania, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • Tubingen, Germania, 72076
        • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
  • Regno Unito
      • Bath, Regno Unito, BA1 3NG
        • The Rice Centre; Royal United Hospital
      • Brentford, Regno Unito, TW8 8DS
        • West London Research Unit; Brentford Lodge
      • Brighton, Regno Unito, BN2 5BE
        • Royal Sussex County Hospital, CIRU Level 5
      • Glasgow, Regno Unito, G20 0XA
        • Glasgow Memory Clinic
      • London, GT LON, Regno Unito, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery; Dementia Research Center
      • Southampton, Regno Unito, SO30 3JB
        • Moorgreen Hospital; Memory Assessment & Rsch Ctr
      • Southampton, Regno Unito, SO16 6YD
        • Southampton General Hospital; Pharmacy
      • Swindon, Regno Unito, SN3 6BW
        • Great Western Hosp.; Kingshill Research Ctr
  • Spagna
      • Albacete, Spagna, 2006
        • Complejo Hospitalario Universitario de Albacete
      • Madrid, Spagna, 28006
        • Clinica Ruber, 4 planta; Servicio de Neurologia
    • Barcelona
      • BArcelon, Barcelona, Spagna, 08034
        • Fundació ACE
      • San Cugat Del Valles, Barcelona, Spagna, 08195
        • Hospital General de Catalunya
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spagna, 20009
        • Policlinica Guipuzcoa
    • Vizcaya
      • Barakaldo, Vizcaya, Spagna, 48903
        • Hospital de Cruces; Servicio de Neurologia
  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85006
        • Banner Alzheimer's Institute
      • Scottsdale, Arizona, Stati Uniti, 85259
        • Mayo Clinic
      • Sun City, Arizona, Stati Uniti, 85351
        • Banner Sun Health Research Insitute
    • California
      • Encino, California, Stati Uniti, 91316
        • Pharmacology Research Inst
      • Fresno, California, Stati Uniti, 93720
        • Margolin Brain Institute
      • La Jolla, California, Stati Uniti, 92037
        • Univ of CA San Diego; Neurosciences Comp.Alzheimer's
      • Los Angeles, California, Stati Uniti, 90095
        • University of California Los Angeles (UCLA)
      • Los Angeles, California, Stati Uniti, 90033
        • USC School of Medicine
      • Newport Beach, California, Stati Uniti, 92660
        • Pharmacology Research Inst
      • Oxnard, California, Stati Uniti, 93030
        • Pacific Neuroscience Med Grp
      • Palo Alto, California, Stati Uniti, 94304
        • Stanford Univ Medical Center
      • Sacramento, California, Stati Uniti, 95817
        • University of California Davis Medical System
      • San Diego, California, Stati Uniti, 92103
        • Pacific Research Network - PRN
      • San Francisco, California, Stati Uniti, 94117
        • Uni of California San Francisco
      • Santa Rosa, California, Stati Uniti, 95403
        • Redwood Regional Medical Group
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06511
        • Yale University
    • Florida
      • Boca Raton, Florida, Stati Uniti, 33431
        • Florida Atlantic University; College of Medicine
      • Brooksville, Florida, Stati Uniti, 34601
        • Meridien Research
      • Delray Beach, Florida, Stati Uniti, 33445
        • Brain Matters Research, Inc.
      • Miami, Florida, Stati Uniti, 33137
        • Miami Jewish Health Systems; Clinical Research
      • Naples, Florida, Stati Uniti, 34105
        • Collier Neurologic Specialists
      • Orlando, Florida, Stati Uniti, 32806
        • Bioclinica Research
      • Tampa, Florida, Stati Uniti, 33609
        • Axiom Clinical Research of Florida
      • West Palm Beach, Florida, Stati Uniti, 33407
        • Premiere Research Institute
    • Georgia
      • Decatur, Georgia, Stati Uniti, 30033
        • DeKalb Neurology Associates
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Rush Alzheimer's Disease Cntr.
      • Elk Grove Village, Illinois, Stati Uniti, 60007
        • Alexian Brothers Neurosci Inst
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana Univ School of Med
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70114
        • Louisiana Research Associates
    • Mississippi
      • Hattiesburg, Mississippi, Stati Uniti, 39401
        • Hattiesburg Clinic
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63132
        • Millennium Psychiatric Associates, LLC
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Cleveland Clinic Lou Ruvo; Center for Brain Research
    • New Jersey
      • Eatontown, New Jersey, Stati Uniti, 07724
        • Memory Enhancement Center of America, Inc.
      • Mount Arlington, New Jersey, Stati Uniti, 07856
        • NeuroCognitive Institute
    • New York
      • Latham, New York, Stati Uniti, 12210
        • Empire Neurology, PC
      • Manhasset, New York, Stati Uniti, 11030
        • Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
      • New York, New York, Stati Uniti, 10032
        • Columbia University Medical Center
      • Rochester, New York, Stati Uniti, 14627
        • University of Rochester Medical Center; Monroe Community Hospital
      • Rochester, New York, Stati Uniti, 14642
        • Investigational Drug Service; Univ of Rochester Medical Ctr
    • North Carolina
      • Raleigh, North Carolina, Stati Uniti, 27607-6520
        • Raleigh Neurology Associates
    • Oregon
      • Portland, Oregon, Stati Uniti, 97210
        • Summit Research Network Inc.
    • Pennsylvania
      • Jenkintown, Pennsylvania, Stati Uniti, 19046
        • The Clinical Trial Center, LLC
    • Rhode Island
      • East Providence, Rhode Island, Stati Uniti, 02914
        • Rhode Island Mood & Memory Research Institute
      • Providence, Rhode Island, Stati Uniti, 02906
        • Butler Hospital
    • South Carolina
      • North Charleston, South Carolina, Stati Uniti, 29425
        • Medical Uni of South Carolina
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
    • Vermont
      • Bennington, Vermont, Stati Uniti, 05201
        • Clinical Neuroscience Research Associates, Inc.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Droga: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Altri nomi:
  • RO5490245

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Adverse Events (AEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genentech, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 dicembre 2012

Completamento primario (Effettivo)

8 febbraio 2017

Completamento dello studio (Effettivo)

8 febbraio 2017

Date di iscrizione allo studio

Primo inviato

6 novembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2012

Primo Inserito (Stima)

8 novembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 febbraio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 febbraio 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Interventi farmacologici

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CROs in Austria

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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