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

NCT04339413

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Alzheimer Disease

Interventions: Gantenerumab

Countries: United States, Argentina, Australia, Canada, Chile, Denmark, Italy, Japan

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (56)
  • Sun City, Arizona, United States
  • Sherman Oaks, California, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • The Villages, Florida, United States
  • Kalamazoo, Michigan, United States
  • Staten Island, New York, United States
  • Matthews, North Carolina, United States
  • Tulsa, Oklahoma, United States
  • Cordova, Tennessee, United States
  • Austin, Texas, United States
  • Ciudad Autonoma Buenos Aires, Argentina
  • Woodville, South Australia, Australia
  • Heidelberg West, Victoria, Australia
  • Halifax, Nova Scotia, Canada
  • Halifax, Nova Scotia, Canada
  • Peterborough, Ontario, Canada
  • Toronto, Ontario, Canada
  • Québec, Canada
  • Santiago, Chile
  • København Ø, Denmark
  • Modena, Emilia-Romagna, Italy
  • Brescia, Lombardy, Italy
  • Brescia, Lombardy, Italy
  • Castellanza, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Chiba, Japan
  • Chiba, Japan
  • Hiroshima, Japan
  • Guadalajara, Mexico CITY (federal District), Mexico
  • + 26 more on CT.gov