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

Phase 3

Terminated

Conditions: Alzheimer's Disease

Interventions: Drug: Crenezumab

Registration Number: NCT03491150

Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 149

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Anti-Crenezumab Antibodies	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.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (66): 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
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Shankle Clinic
🇺🇸Newport Beach, California, United States