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A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

NCT04374253

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Alzheimer Disease

Interventions: Gantenerumab, Gantenerumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China

This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
* The participant should be capable of completing assessments either alone or with the help of the caregiver
* Availability of a person (referred to as the "caregiver")
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of \<1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) 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:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
* Prematurely discontinued from Study WN29922 or WN39658
* Any medical condition that 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
* Evidence of disseminated 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
Locations (268)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Sun City, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Fullerton, California, United States
  • Fullerton, California, United States
  • Irvine, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • Santa Ana, California, United States
  • Sherman Oaks, California, United States
  • Simi Valley, California, United States
  • New Haven, Connecticut, United States
  • Norwalk, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Atlantis, Florida, United States
  • Bradenton, Florida, United States
  • Bradenton, Florida, United States
  • Delray Beach, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Ocala, Florida, United States
  • Sarasota, Florida, United States
  • Sunrise, Florida, United States
  • Tampa, Florida, United States
  • Wellington, Florida, United States
  • Atlanta, Georgia, United States
  • Gainesville, Georgia, United States
  • Springfield, Illinois, United States
  • + 238 more on CT.gov