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Long-Term Gantenerumab in Alzheimer's Disease (POSTGRADUATE)
NCT04374253Phase 3
Key facts
- Status
- Terminated
- Start
- Jan 2021
- Primary completion
- Mar 2023
- Countries
- 29
- Sponsor
- Roche
- Modality
- Monoclonal Antibodies
- Drugs
- gantenerumab
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 3, open-label trial of gantenerumab in Alzheimer's disease (AD) (2 arms), sponsored by Roche. Primary endpoints: Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE) up to 134 weeks, Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) up to 134 weeks and 3 more. Started Jan 2021; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Group 1
Participants from parent double-blind part who did not enter OLE
Group 2
Participants from parent OLE part
03
Who it enrols
Participants with Alzheimer's Disease who completed the parent studies (WN29922/GRADUATE I or WN39658/GRADUATE II) without premature discontinuation. Requires caregiver availability and strict contraception/abstinence.
04
Endpoints
Primary
Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)
Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI
Number of Participants With Injection-Site Reactions (ISRs)
Secondary
Change From Baseline Over Time in Clinical Dementia Rating - Global Score
Change From Baseline Over Time in Clinical Dementia Rating - Sum of Boxes
Change From Baseline Over Time in Mini-Mental State Examination Score
Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 Score
Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 Score
Change From Baseline Over Time in Verbal Fluency Task Score
Change From Baseline Over Time in Coding (Digit Symbol Substitution Test) Subset
Change in Functional Activities Questionnaire Score
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