Alzheimer’s disease (AD) MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Previous participation in Study BN29552 or BN29553 and completion of the Week 105 visit •Able to provide written consent signed by the patient or the patient’s authorized representative under applicable local law •A caregiver, defined as: –Has frequent and sufficient contact with the patient to be able to provide accurate information regarding the patient’s cognitive and functional abilities –Be in sufficiently good general health •Willingness and ability to complete all aspects of the study •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 or use contraceptive measures, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 375
Exclusion criteria
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 at the Study BN29552 or BN29553 Week 105 visit, as assessed by central review of MRI •Diagnosed with three recurrent, symptomatic ARIA-E events or exacerbations of previous events •Presence of intracranial lesion that could potentially increase the risk of CNS bleeding (e.g., intracranial aneurysm; arterio-venous malformation) •At risk of suicide in the opinion of the investigator •Alcohol and/or substance abuse or dependence (according to Diagnostic and Statistical Manual of Mental Disorders Version 5 criteria) within the past 2 years and during the study (nicotine use is allowed; marijuana use is not allowed within the past 2 years) •Inability to tolerate MRI procedures or contraindication to 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 •Chronic use of anticoagulants or participation in any other investigational drug treatment trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: T-o assess the long-term safety and tolerability of crenezumab (60 mg/kg IV Q4W) in eligible patients with AD who participated in Study BN29552 or BN29553 and completed the Week 105 study visit.; Secondary Objective: For exploratory efficacy objectives, the study aims to evaluate the long-term effect of crenezumab on global outcomes of disease progression, cognition, disease severity, patient dependence, patient function, patient behaviour and neuropsychological symptoms, health-related quality of life, and effect on caregiver burden. For exploratory pharmacokinetic objectives, the study aims to evaluate PK characteristics of crenezumab and to explore exposure-response relationships in patients with prodromal to mild Alzheimer’s disease. For exploratory biomarker objectives, the study aims to evaluate the effect of crenezumab on biomarkers. ; Primary end point(s): 1.Nature, frequency, severity, and timing of adverse events and serious adverse events 2.Incidence of adverse events of special interest, specifically pneumonia 3.Changes in vital signs, clinical laboratory tests, Electrocardiogram assessments from baseline over time 4.Changes in Columbia-Suicide Severity Rating Scale (CSSR-S) scores from baseline over time 5.Adverse events as assessed by MRI: amyloid-related imaging abnormalities edema/effusion and ARIA H 6.Incidence of immunogenicity as evidenced by antibodies to crenezumab or other components of drug product ; Timepoint(s) of evaluation of this end point: 1-2. Up to 4 years 3. From baseline up to 4 years 4. From baseline, OLE Weeks 25, 53, 77, 105 and every 52 weeks thereafter and follow-up for patients discontinuing OLE and completing OLE treatment 5. At Weeks 13, 25, 53, 105, and every 52 weeks thereafter an | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Lithuania, Portugal, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed