Alzheimer’s Disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Sponsors
Roche Farma S.A.(Soc. Unipersonal)que realiza el ensayo en España y que actúa como representante F.Hodmann-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, must follow protocol specified acceptable methods of contraception •For men with female partners of childbearing potential, must follow protocol specified acceptable methods of contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=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 •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: To 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): •Nature, frequency, severity, and timing of adverse events, serious adverse events, and adverse events of special interest •Physical and neurologic examinations, vital signs, blood tests, ECGs, and C-SSRS •Incidence of ARIA E and ARIA H •The immunogenic potential of crenezumab;Timepoint(s) of evaluation of this end point: Change from baseline at Week 105 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For exploratory efficacy endpoints, change from baseline in the double-blind treatment period of BN29552 or BN29553 in BN40031 for CDR-SB, ADAS-Cog13, ADAS-Cog12, MMSE, CDR-GS, ADCS-ADL, FAQ, NPI-Qz, QoL-AD and ZCI-AD. For exploratory pharmacokinetic endpoints, serum concentrations of crenezumab, CSF concentrations of crenezumab, correlation between crenezumab concentration and biomarkers as well as safety and efficacy outcomes. For exploratory biomarker endpoints, brain amyloid load over time measured by PET, brain tau load and spread over time measured by PET, CSF markers of disease change over time, plasma pharmacodynamic markers of disease over time and MRI derived measurements over time;Timepoint(s) of evaluation of this end point: Weeks 25, 53, 77, 105 and every year thereafter, as well as at follow up 4 weeks after the last dose. | — |
Countries
Belgium, Denmark, Finland, France, Germany, Hungary, Lithuania, Spain, Sweden, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed