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

JRCT ID: jRCT2031200328

Registered date:28/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 04/02/2021
• Target sample size: 2032
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Canada,Japan,Chile,Japan,Croatia,Japan,Denmark,Japan,Finland,Japan,Hungary,Japan,Italy,Japan,Korea,Japan,Lithuania,Japan,Mexico,Japan,Netherlands,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Russian Federation,Japan,Sweden,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Group 1: participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg sub-cutaneously (SC) every 2 weeks (Q2W).
Group 2: participants who have completed OLE part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W)

Outcome(s)

Primary Outcome

Safety
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline (OLE Day 1) to Week 104 ]
- Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: From Baseline (OLE Day 1) to Week 104 ]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: From Baseline (OLE Day 1) to Week 104 ]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI [ Time Frame: From Baseline (OLE Day 1) to Week 104 ]
- Percentage of Participants with Injection-Site Reactions (ISRs) [ Time Frame: From Baseline (OLE Day 1) to Week 104 ]

Secondary Outcome

Efficacy, Phamacokinetics, Other
- Change in Clinical Dementia Rating (CDR) [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Mini-Mental State Examination (MMSE) [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADASCog13) [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Verbal Fluency Task Score [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Coding [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Functional Activities Questionnaire (FAQ) [ From Baseline (OLE Day 1) to Week 104 ]
- Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) [ From Baseline (OLE Day 1) to Week 104 ]
- Plasma Concentration of Gantenerumab Administered SC [ From Baseline (OLE Day 1) to Week 104 ]
- Percentage of Participants with Anti-drug Antibody (ADA) to Gantenerumab [ From Baseline (OLE Day 1) to Week 104 ]

Key inclusion & exclusion criteria

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

Include criteria

- 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
- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Geoffrey A Kerchner, M.D., Ph.D.
• Secondary ID(s): NCT04374253