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

Stopped early · Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT04374253

Run by

Hoffmann-La Roche

People needed

1382

Starts

2021-01-26

Expected to finish

2023-03-06

Last updated by the study team

2024-05-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Banner Sun Health Research Insitute — Sun City, Arizona, United States
• Health Initiatives Research, PLLC — Fayetteville, Arkansas, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Desert Valley Research — Redlands, California, United States
• Sutter Medical Group, Neurology — Sacramento, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States
• Southern California Research LLC — Simi Valley, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• JEM Research LLC — Atlantis, Florida, United States
• Accel Research Sites - CRU Tampa — Bradenton, Florida, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Brain Matters Research, Inc. — Delray Beach, Florida, United States
• ClinCloud, LLC — Maitland, Florida, United States
• Optimus U Corp — Miami, Florida, United States
• Allied Biomedical Research Institute, Inc — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Intercoastal Medical Group — Sarasota, Florida, United States
• Infinity Clinical Research, LLC — Sunrise, Florida, United States
• Banner Alzheimer?s Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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