None listed
Conditions
Interventions
Group 1 Type of group
For participants who completed the double-blind part and did not enter the OLE part of StudyWN29922 or WN39658: The first administration of open-label gantenerumab should take place approximately 2 weeks after the Week 104 visit of Study WN29922 or WN39658 and will be considered the OLE baseline visit (OLE Day 1).
Group name:Group 2 Type of group
For participants who completed the double-blind part and the OLE part of Study WN29922 or WN39658, the first administration of gantenerumab in this study should take place approximately 2 weeks after the OLE Week 34 visit or the finaldose visit in the Study WN29922 or WN39658 OLE. Participants who have a gap in their transition between the OLE part of the parent study (WN29922 or WN39658) and this study, for unforeseen reasons, will roll over to this study continuing the schedule of activities
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria:  Signed Informed Consent Form by the participant with AD and/or the legal authorized representative as per local requirements  Completed Study WN29922 or WN39658, either its double-blind part (participants have reached the 510 mg Q2W dose schedule by the time of completion) or OLE part (participants have received at least 3 doses of 510 mg Q4W), and did not discontinue study drug early  Ability to comply with the study protocol  Willingness and ability to complete all aspects of the study (including MRI and lumbar puncture [if applicable]).  The participant should be capable of completing assessments either alone or with the help of the caregiver.  For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of 1% per year during the treatment period and for at least 16 weeks after the final dose of gantenerumab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
Exclusion criteria
Exclusion criteria:  Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug Women of childbearing potential must have a negative urine pregnancy test at the final visit of the parent study.  Prematurely discontinued from Study WN29922 or WN39658, either its double-blind or OLE part, as applicable, or from study drug, for any reason  Any medical condition that the investigator or Sponsor determines may jeopardize the participant’s safety if he or she continues to receive study treatment  Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part, as applicable  Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)  Evidence of intracerebral macrohemorrhage  Use of prohibited medication  Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part, as applicable Participants should remain in the parent study, as governed by that protocol, and may enroll in this study once the ARIA-E is resolved.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:By Physicians follo-up Measure:Nature, frequency, severity, and timing of adverse events and serious adverse events Timepoints:Throughout the study ; Outcome name:Vital signs, blood tests, and Columbia-Suicide Severity Rating Scale (C-SSRS) Measure:Physical examinations (including neurologic systems) Timepoints:Throughout the study ; Outcome name:By Physicians follow-up Measure:Nature, frequency, severity, and timing of ARIA-E and ARIA-H Timepoints:Throughout the study ; Outcome name:By Physicians follow-up Measure:Nature, frequency, severity, and timing of ISRs Timepoints:Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:– Clinical Dementia Rating (CDR) – Mini-Mental State Examination (MMSE) – Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) and Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADASCog13) – Verbal Fluency Task – Coding – Functional Activities Questionnaire (FAQ) – Alzheimer Disease Cooperative Study Group -Activities of Daily Living (ADCSADL) Measure:Change over time in cognition, function, and other outcomes. Timepoints:Throughout the study ; Outcome name:To measure plasma concentration of gantenerumab administered SC at specified timepoints Measure:Characterize the PK profile Timepoints:Troughtout the study. ; Outcome name:Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study Measure:the immune response to gantenerumab Timepoints:Throughout the study ; Outcome name: Brain amyloid load over time, as measured by amyloid PET scan in a subset of participants  Brain tau load over time, as measured by tau PET scan in a subset of participants  CSF markers of disease over time in a subset of participants, including, but not limited to, A1−42, total tau (t-tau), and phosphorylated tau(p-tau)  MRI-derived measurements over time, such as volumetric changes in whole brain, ventricles, hippocampus, or other structures; changes in functional brain connectivity; or changes in the integrity of white matter in all participants  Blood and Plasma markers over time Measure:Long-term effectsof gantenerumab Timepoints:Throughout the study ; Outcome name:Health outcomes in participant and caregiver, as measured by EuroQol 5-Dimension Questionnaire(EQ-5D) Measure:The exploratory health status utility Timepoints:Throughout the study | — |
Countries
Argentina, Belgium, Chile, Denmark, Finland, Korea South, Mexico, Nederland, Peru, Russian Federation, Switzerland, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactCinthya Barrantes
ROCHE FARMA (PERU) S.A.
Outcome results
None listed