An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Crenezumab
Intervention description: Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open Label Extension (OLE)
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Healthy volunteers: No
Keywords: Dementia; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

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.