AN OPEN-LABEL, MULTICENTER, ROLLOVER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM GANTENERUMAB ADMINISTRATION IN PARTICIPANTS WITH ALZHEIMER'S DISEASE
- Conditions
- eurologisch: ziekte van alzheimerAlzheimer's Diseasedementia
- Registration Number
- NL-OMON52334
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
• 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
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety/Tolerability:<br /><br>• Nature, frequency, severity, and timing and outcomes of adverse events and<br /><br>serious adverse events<br /><br>• Physical examinations (including neurologic systems), vital signs, blood<br /><br>tests, and Columbia-Suicide Severity Rating Scale (C-SSRS)<br /><br>• Nature, frequency, severity, and timing of ARIA-E and ARIA-H<br /><br>• Nature, frequency, severity, timing and outcomes of ISRs<br /><br>• Incidence of treatment discontinuations of adverse events<br /><br>• Incidence of adverse events of special interest</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy:<br /><br>• Change over time in cognition, function, and other outcomes as measured by<br /><br>the following:<br /><br>- Clinical Dementia Rating (CDR)<br /><br>- Mini-Mental State Examination (MMSE)<br /><br>- Alzheimer Disease Assessment Scale*Cognition, Subscale 11 (ADAS-Cog11) and<br /><br>Alzheimer Disease Assessment Scale Cognition, Subscale 13 (ADAS-Cog13)<br /><br>- Verbal Fluency Task<br /><br>- Coding<br /><br>- Functional Activities Questionnaire (FAQ)<br /><br>- Alzheimer Disease Cooperative Study Group*Activities of Daily Living<br /><br>(ADCS-ADL)<br /><br>- Immunogenicity: prevalence of ADA's at baseline and incidence of ADA's<br /><br>during the study</p><br>