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

JRCT ID: jRCT2061200043

Registered date:08/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 08/01/2021
• Target sample size: 116
• Countries of recruitment: AUSTRALIA,Japan,CANADA,Japan,CHILE,Japan,ITALY,Japan,MEXICO,Japan,NETHERLANDS,Japan,POLAND,Japan,RUSSIAN FEDERATION,Japan,KOREA,Japan,SPAIN,Japan,SWITZERLAND,Japan,TURKEY,Japan,UNITED KINGDOM,Japan,UNITED STATES,Japan,ARGENTINA,Japan,DENMARK,Japan
• Study type: Interventional
• Intervention(s): Gantenerumab will be administered as SC injection Q4W

Outcome(s)

Primary Outcome

Safety
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 Outcome: none

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Szofia S Bullain, M.D.
• Secondary ID(s): NCT04339413