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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061200043

Registered date:08/01/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedAlzheimer's disease
Date of first enrollment08/01/2021
Target sample size173
Countries of recruitmentAUSTRALIA,CANADA,CHILE,ITALY,MEXICO,NETHERLANDS,POLAND,RUSSIAN FEDERATION,KOREA,SPAIN,SWITZERLAND,TURKEY,UNITED KINGDOM,UNITED STATES,ARGENTINA,DENMARK,Japan
Study typeInterventional
Intervention(s)Gantenerumab will be administered as SC injection Q4W

Outcome(s)

Primary OutcomeSafety 1.Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Day 1) up to Week 104 ] 2.Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline (Day 1) up to Week 104 ] 3.Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline (Day 1) up to Week 104 ] 4.Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI [ Time Frame: Baseline (Day 1) up to Week 104 ] 5.Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab [ Time Frame: Baseline (Day 1) up to Week 104 ] 6.Percentage of Participants with Injection-Site Reactions [ Time Frame: Baseline (Day 1) up to Week 104 ] 7.Percentage of Participants Who Discontinued Treatment due to AEs [ Time Frame: Baseline (Day 1) up to Week
Secondary Outcomenone

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteria-Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 -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
Exclude 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 microhemorrhage

Related Information

Contact

Public contact
Name Clinical trials information
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co., Ltd.
Scientific contact
Name Szofia S Bullain, M.D.
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation F. Hoffmann-La Roche Ltd