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

Stopped early · Phase 3

Conditions studied: Alzheimer Disease

In brief

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

Key facts

Study ID

NCT04339413

Run by

Hoffmann-La Roche

People needed

116

Starts

2020-05-22

Expected to finish

2023-01-04

Last updated by the study team

2024-01-18

Who can join

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

You may qualify if…

• Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
• Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
• For Part 1 and Part 2:
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
• Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
• Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant

You may not qualify if…

• Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
• Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
• If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
• Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
• Pregnancy
• Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
• Evidence of intracerebral macrohemorrhage
• Part 2: Participants who have been discontinued from Part 1 of the study

Where it is running

• California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States
• Accelerated Enrollment Solutions — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Bioclinica The Villages — The Villages, Florida, United States
• Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research — Kalamazoo, Michigan, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Alzheimer's Memory Center — Matthews, North Carolina, United States
• Central States Research — Tulsa, Oklahoma, United States
• Neurology Clinic PC — Cordova, Tennessee, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• Instituto Neurologia Bs As — Ciudad Autonoma Buenos Aires, Argentina
• The Queen Elizabeth Hospital; Neurology — Woodville, South Australia, Australia
• Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre — Heidelberg West, Victoria, Australia
• Centricity Research — Halifax, Nova Scotia, Canada
• True North Clinical Research-Halifax — Halifax, Nova Scotia, Canada
• Kawartha Centre - Redefining Healthy Aging — Peterborough, Ontario, Canada
• Toronto Memory Program — Toronto, Ontario, Canada
• Alpha Recherche Clinique — Québec, Canada
• Especialidades Medicas LYS — Santiago, Chile
• Rigshospitalet, Hukommelsesklinikken — København Ø, Denmark
• Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze — Modena, Emilia-Romagna, Italy
• Azienda Ospedaliera Spedali Civili; Scienze Neurologiche — Brescia, Lombardy, Italy
• IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer — Brescia, Lombardy, Italy
• Irccs Multimedica Santa Maria; Unita' Di Neurologia — Castellanza, Lombardy, Italy
• Banner Sun Health Research Insitute — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.