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



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:3/30/2019
Start Date:April 11, 2018
End Date:May 29, 2019

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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 IV Q4W will be offered to all
patients who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to
evaluate safety in patients 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.


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.
We found this trial at
39
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800 Biesterfield Road
Elk Grove Village, Illinois 60007
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3924 9th Avenue West
Bradenton, Florida 34205
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6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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3212 Cove Bend Drive
Tampa, Florida 33613
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400 Patroon Creek Boulevard
Albany, New York 12206
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Austin, Texas 78757
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501 Billingsley Road
Charlotte, North Carolina 28211
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8198 Walnut Hill Lane
Dallas, Texas 75231
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Danbury, Connecticut 06810
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Darlinghurst, New South Wales 2010
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Decatur, Georgia 30033
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Delray Beach, Florida 33445
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Flowood, Mississippi 39232
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Greensboro, North Carolina 27405
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Lake Worth, Florida 33449
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Miami, Florida 33137
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New Haven, Connecticut 06510
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Newport Beach, California 92663
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Norwalk, Connecticut 06851
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Oklahoma City, Oklahoma 73116
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100 West Gore Street
Orlando, Florida 32806
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Port Orange, Florida 32127
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Portland, Oregon 97210
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10 East Cambridge Circle Drive
Prairie Village, Kansas 66206
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Redlands, California 92374
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Richmond, VA
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San Francisco, California 94143
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11600 Wilshire Boulevard
Santa Monica, California 90025
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Scarborough, Maine 04074
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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Springfield, New Jersey 07081
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4001 East Fletcher Avenue
Tampa, Florida 33613
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Toms River, New Jersey 08757
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Torrance, California 90502
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Willow Grove, Pennsylvania 19090
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