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Gantenerumab Pharmacodynamics in Early Alzheimer's (GRADUATION)
NCT04592341Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2020
- Primary completion
- Jan 2023
- Countries
- 8
- Sponsor
- Roche
- Modality
- Monoclonal Antibodies
- Drugs
- gantenerumab
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 2, open-label, single-arm trial of gantenerumab in Alzheimer's disease (AD), sponsored by Roche. Primary endpoint: Change From Baseline in Brain Amyloid Load as Measured by [18F] Florbetaben PET at Week 104. Started Nov 2020; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Gantenerumab
Participants receive gantenerumab SC with a titration schedule reaching 255 mg Q1W.
03
Who it enrols
Participants aged 50-90 with probable AD or prodromal AD, confirmed amyloid pathology by PET, MMSE >= 22, and CDR-GS 0.5 or 1.0.
04
Endpoints
Primary
Change From Baseline in Brain Amyloid Load as Measured by [18F] Florbetaben PET
Secondary
Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E)
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H)
Number of Participants With Injection-Site Reactions (ISR)
Number of Participants With Treatment-emergent Anti-Drug Antibodies to Gantenerumab
Plasma Concentration of Subcutaneous (SC) Gantenerumab
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