An Open-Label Crenezumab Study in Participants With Alzheimer's Disease (CREAD OLE)

June 25, 2020 updated by: Hoffmann-La Roche

A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease

In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg West, Victoria, Australia, 3081
        • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
    • Western Australia
      • West Perth, Western Australia, Australia, 6005
        • Neurodegenerative Disorders Research; Neurology
  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital; Geriatric Medicine
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M4G 3E8
        • The Centre for Memory and Aging
      • Woodstock, Ontario, Canada, N4S 5P5
        • Devonshire Clinical Research Inc.
  • Finland
      • Tampere, Finland, 33100
        • Terveystalo Tampere
  • France
      • Toulouse Cedec, France, 31059
        • Hopital La Grave; Place Lange
  • Germany
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital; Dept. of Medicine & Therapeutics
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00186
        • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
      • Roma, Lazio, Italy, 00179
        • Fondazione Santa Lucia IRCCS
  • Korea, Republic of
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santariskiu Clinic
  • Mexico
      • Culiacan, Mexico, 80020
        • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
      • Monterrey, Mexico, 64710
        • AVIX Investigación Clínica S.C
      • Monterrey, Mexico, 64460
        • Hospital Uni; Dr. Jose E. Gonzalez
      • Saltillo, Mexico, 25000
        • Hospital Universitario de Saltillo
  • Poland
      • Warszawa, Poland, 01-684
        • Centrum Medyczne NeuroProtect
  • Russian Federation
      • Kazan, Russian Federation, 420021
        • State Autonomous Healthcare Institution "Republican Clinical Neurological Center
      • Kazan, Russian Federation, 420101
        • State autonomous institution of healthcare Inter-regional clinical and diagnostic center
      • St. Petersburg, Russian Federation, 190121
        • SHI City Psychoneurological Dispensary #7 (with Hospital)
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Neurologia
    • Barcelona
      • BArcelon, Barcelona, Spain, 08034
        • Fundació ACE
      • Sant Cugat del Valles, Barcelona, Spain, 8195
        • Hospital General De Catalunya; Servicio de Neurologia
      • Terrassa, Barcelona, Spain, 08222
        • Hospital Mutua De Terrasa; Servicio de Neurologia
    • Caceres
      • Plasencia, Caceres, Spain, 10600
        • Hospital Virgen del Puerto. Servicio de Neurología
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra; Servicio de Neurología
  • Turkey
      • Samsun, Turkey, 55139
        • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • United Kingdom
      • Chertsey, United Kingdom, KT16 0AE
        • Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Shankle Clinic
      • Redlands, California, United States, 92374
        • Anderson Clinical Research, Inc.
      • Sacramento, California, United States, 95817
        • University of California, Davis; Alzheimers Disease Center, Department of Neurology
      • San Francisco, California, United States, 94158
        • UCSF - Memory and Aging Center
      • Santa Monica, California, United States, 90404
        • Neurological Research Inst
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Associated Neurologists PC - Danbury
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Institute For Neurodegenerative Disorders
      • Norwalk, Connecticut, United States, 06851
        • Research Center for Clinical Studies, Inc.
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research, Inc.
      • Lake Worth, Florida, United States, 33414
        • Alzheimer's Research and Treatment Center
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Orlando, Florida, United States, 32806
        • Bioclinica Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials, LLC
    • Georgia
      • Decatur, Georgia, United States, 30033
        • NeuroStudies.net, LLC
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neurosci Inst
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University, School of Medicine
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • MidAmerica Neuroscience Institute
    • Maine
      • Scarborough, Maine, United States, 04074
        • MMP Neurology
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive and Research Center of New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Institute of NJ
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Behavioral Health Research
      • Greensboro, North Carolina, United States, 27401
        • Guilford Neurologic Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Oklahoma Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network Inc.
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Medical Group
      • Richmond, Virginia, United States, 23294
        • National Clinical Research Inc.-Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous participation in Study BN29552 or BN29553 and completion of the Week 105 visit.
  • Able to provide written informed consent by the patient or legally authorized representative, if required.
  • Every effort to have the same caregiver participate throughout the duration of the OLE (Open Label Extension) study who also participated in Study BN29552 or BN29553.
  • Willingness and ability to complete all aspects of the study [including MRI (Magnetic Resonance Imaging), lumbar puncture [if applicable], and PET (Positron Emission Tomography) imaging [if applicable].
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a protocol approved contraceptive method and agreement to refrain from donating eggs for at least 8 weeks after last dose.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a protocol approved contraceptive method for at least 8 weeks after last dose.

Exclusion Criteria:

  • Patients who discontinued treatment permanently in Study BN29552 or BN29553 for safety reasons.
  • Impaired coagulation.
  • Evidence of more than 10 microbleeds and/or ARIA-H (amyloid-related imaging abnormalities-hemosiderin deposition) at the Study BN29552 or BN29553 Week 105 visit, as assessed by central review of MRI.
  • Diagnosed with three recurrent, symptomatic ARIA-E (amyloid-related imaging abnormalities-edema/effusion) events or exacerbations of previous events.
  • Presence of intracranial lesion that could potentially increase the risk of CNS (Central Nervous System) bleeding.
  • At risk of suicide in the opinion of the investigator.
  • Alcohol and/or substance abuse or dependence within the past 2 years and during the study.
  • Inability to tolerate MRI procedures or contraindication to MRI, including, but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan; or any other clinical history or examination finding that, in the judgment of the investigator, would pose a potential hazard in combination with MRI.
  • Pregnant or lactating, or intending to become pregnant during the study.
  • Any other severe or unstable medical condition that, in the opinion of the investigator or Sponsor, could be expected to progress, recur, or change to such an extent that it could put the patient at special risk, bias the assessment of the clinical or mental status of the patient to a significant degree, or interfere with the patient's ability to complete the study assessments.
  • Chronic use of anticoagulants or participation in any other investigational drug treatment trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Parent Placebo
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
Drug: Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Other Names:
  • RO5490245
EXPERIMENTAL: Parent Crenezumab
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
Drug: Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Other Names:
  • RO5490245

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to 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.
Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
Percentage of Participants With Anti-Crenezumab Antibodies
Time Frame: Baseline up to end of study (up to 54 weeks).
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Baseline up to end of study (up to 54 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2018

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (ACTUAL)

April 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BN40031
  • 2017-002702-12 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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