Neurologisch: ziekte van alzheimer Alzheimer's Disease dementia
Conditions
Interventions
Subjects in the Netherlands: For participants who completed the double-blind
part and did not enter the OLE part of Study WN39658: The first administration
of open-label gantenerumab should take pla
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form by the participant with AD and/or the legal authorized representative as per local requirements • Completed WN39658 or WN29922 study, 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). • availability of a caregiver • 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. • agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
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 WN39658 or WN29922, its double-blind part, or OLE part, 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 WN39658 of WN29922, its double-blind part or OLE part. • 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 WN39658 or WN29922, its double-blind or OLE part 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 |
|---|---|
| Safety/Tolerability: • Nature, frequency, severity, and timing and outcomes of adverse events and serious adverse events • Physical examinations (including neurologic systems), vital signs, blood tests, and Columbia-Suicide Severity Rating Scale (C-SSRS) • Nature, frequency, severity, and timing of ARIA-E and ARIA-H • Nature, frequency, severity, timing and outcomes of ISRs • Incidence of treatment discontinuations of adverse events • Incidence of adverse events of special interest | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: • Change over time in cognition, function, and other outcomes as measured by the following: - 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 (ADAS-Cog13) - Verbal Fluency Task - Coding - Functional Activities Questionnaire (FAQ) - Alzheimer Disease Cooperative Study Group*Activities of Daily Living (ADCS-ADL) - Immunogenicity: prevalence of ADA's at baseline and incidence of ADA's during the study | — |
Countries
Netherlands
Outcome results
None listed