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
- -G30G30
- Registration Number
- PER-036-20
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method