Clinical trial NCT03491150: An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
Official title: A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Dementia
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-04-09
Enrollment: 149
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Extension (OLE)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
measure: Percentage of Participants With Anti-Crenezumab Antibodies
timeFrame: Baseline up to end of study (up to 54 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Shankle Clinic
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research, Inc.
state: California
city: Sacramento
country: United States
facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology
state: California
city: San Francisco
country: United States
facility: UCSF - Memory and Aging Center
state: California
city: Santa Monica
country: United States
facility: Neurological Research Inst
state: California
city: Danbury
country: United States
facility: Associated Neurologists PC - Danbury
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research, Inc.
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Decatur
country: United States
facility: NeuroStudies.net, LLC
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosci Inst
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University, School of Medicine
state: Illinois
city: Prairie Village
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Scarborough
country: United States
facility: MMP Neurology
state: Maine
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: Charlotte
country: United States
facility: Behavioral Health Research
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc.-Richmond
state: Virginia
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
state: Victoria
city: West Perth
country: Australia
facility: Neurodegenerative Disorders Research; Neurology
state: Western Australia
city: London
country: Canada
facility: Parkwood Hospital; Geriatric Medicine
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Memory and Aging
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Toulouse Cedec
country: France
facility: Hopital La Grave; Place Lange
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics
city: Roma
country: Italy
facility: Fondazione Santa Lucia IRCCS
state: Lazio
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
state: Lazio
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic
city: Culiacan
country: Mexico
facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
city: Monterrey
country: Mexico
facility: Hospital Uni; Dr. Jose E. Gonzalez
city: Monterrey
country: Mexico
facility: AVIX Investigación Clínica S.C
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Kazan
country: Russian Federation
facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center
city: Kazan
country: Russian Federation
facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center
city: St. Petersburg
country: Russian Federation
facility: SHI City Psychoneurological Dispensary #7 (with Hospital)
city: BArcelon
country: Spain
facility: Fundació ACE
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Hospital General De Catalunya; Servicio de Neurologia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua De Terrasa; Servicio de Neurologia
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto. Servicio de Neurología
state: Caceres
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Neurología
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.; Neurology
city: Chertsey
country: United Kingdom
facility: Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: