An Open-Label Crenezumab Study in Participants With Alzheimer's Disease

NCT ID: NCT03491150

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2019-05-31

Brief Summary

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parent Placebo

Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Group Type: PLACEBO_COMPARATOR

Crenezumab

Intervention Type: DRUG

Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Parent Crenezumab

Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Group Type: EXPERIMENTAL

Crenezumab

Intervention Type: DRUG

Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Interventions

Crenezumab

Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Intervention Type: DRUG

Other Intervention Names

RO5490245

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Shankle Clinic

Newport Beach, California, United States

Anderson Clinical Research, Inc.

Redlands, California, United States

University of California, Davis; Alzheimers Disease Center, Department of Neurology

Sacramento, California, United States

UCSF - Memory and Aging Center

San Francisco, California, United States

Neurological Research Inst

Santa Monica, California, United States

Associated Neurologists PC - Danbury

Danbury, Connecticut, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, United States

Bradenton Research Center

Bradenton, Florida, United States

Brain Matters Research, Inc.

Delray Beach, Florida, United States

Alzheimer's Research and Treatment Center

Lake Worth, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Bioclinica Research

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Stedman Clinical Trials, LLC

Tampa, Florida, United States

NeuroStudies.net, LLC

Decatur, Georgia, United States

Alexian Brothers Neurosci Inst

Elk Grove Village, Illinois, United States

Southern Illinois University, School of Medicine

Springfield, Illinois, United States

MidAmerica Neuroscience Institute

Prairie Village, Kansas, United States

MMP Neurology

Scarborough, Maine, United States

Precise Research Centers

Flowood, Mississippi, United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

Advanced Memory Research Institute of NJ

Toms River, New Jersey, United States

Behavioral Health Research

Charlotte, North Carolina, United States

Guilford Neurologic Associates

Greensboro, North Carolina, United States

Oklahoma Clinical Research

Oklahoma City, Oklahoma, United States

Summit Research Network Inc.

Portland, Oregon, United States

Abington Neurological Associates

Willow Grove, Pennsylvania, United States

Senior Adults Specialty Research

Austin, Texas, United States

Sentara Medical Group

Norfolk, Virginia, United States

National Clinical Research Inc.-Richmond

Richmond, Virginia, United States

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

Heidelberg West, Victoria, Australia

Neurodegenerative Disorders Research; Neurology

West Perth, Western Australia, Australia

Parkwood Hospital; Geriatric Medicine

London, Ontario, Canada

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, Canada

The Centre for Memory and Aging

Toronto, Ontario, Canada

Devonshire Clinical Research Inc.

Woodstock, Ontario, Canada

Terveystalo Tampere

Tampere, , Finland

Hopital La Grave; Place Lange

Toulouse Cedec, , France

Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

München, , Germany

Prince of Wales Hospital; Dept. of Medicine & Therapeutics

Hong Kong, , Hong Kong

Fondazione Santa Lucia IRCCS

Rome, Lazio, Italy

Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

Rome, Lazio, Italy

Vilnius University Hospital Santariskiu Clinic

Vilnius, , Lithuania

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

Culiacán, , Mexico

Hospital Uni; Dr. Jose E. Gonzalez

Monterrey, , Mexico

AVIX Investigación Clínica S.C

Monterrey, , Mexico

Hospital Universitario de Saltillo

Saltillo, , Mexico

Centrum Medyczne NeuroProtect

Warsaw, , Poland

State Autonomous Healthcare Institution "Republican Clinical Neurological Center

Kazan', , Russia

State autonomous institution of healthcare Inter-regional clinical and diagnostic center

Kazan', , Russia

SHI City Psychoneurological Dispensary #7 (with Hospital)

Saint Petersburg, , Russia

Inha University Hospital

Incheon, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Fundació ACE

BArcelon, Barcelona, Spain

Hospital General De Catalunya; Servicio de Neurologia

Sant Cugat del Vallès, Barcelona, Spain

Hospital Mutua De Terrasa; Servicio de Neurologia

Terrassa, Barcelona, Spain

Hospital Virgen del Puerto. Servicio de Neurología

Plasencia, Caceres, Spain

Clinica Universitaria de Navarra; Servicio de Neurología

Pamplona, Navarre, Spain

Hospital Universitario 12 de Octubre; Servicio de Neurologia

Madrid, , Spain

Ondokuz Mayis Univ. Med. Fac.; Neurology

Samsun, , Turkey (Türkiye)

Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit

Chertsey, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

Countries

United States; Australia; Canada; Finland; France; Germany; Hong Kong; Italy; Lithuania; Mexico; Poland; Russia; South Korea; Spain; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-002702-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BN40031

Identifier Type: -

Identifier Source: org_study_id