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    Clinical Trial Results:
    An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease

    Summary
    EudraCT number
    		 2019-004431-23
    Trial protocol
    		 NL   ES   PL   GB   DK   IT  
    Global end of trial date
    04 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2024
    First version publication date
    06 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WN41874
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04339413
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of continued treatment with subcutaneous gantenerumab at the target dose in participants with AD who received gantenerumab in the OLEs of SCarlet RoAD (NCT01224106) and Marguerite RoAD (NCT02051608).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Türkiye: 6
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    116
    EEA total number of subjects
    46
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    83
    85 years and over
    23

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in Part 1 of the study at 56 centers in the United States, Spain, Canada, Italy, Germany, Japan, Korea, Mexico, Poland, Turkey, Australia, Russia, Argentina, Switzerland, Chile, Denmark, and Netherlands from 22 May 2020 to 04 Jan 2023. The study was terminated before Part 2 was initiated.

    Pre-assignment
    Screening details
    		 A total of 116 participants rolled over in this study of which 115 participants received gantenerumab in part 1. 59 participants rolled over from OLE WN25203 & 56 participants rolled over from WN28745. Due to negative pre-planned analysis of studies WN39658 & WN29922, this study was terminated by sponsor, & no participant was rolled over to Part 2.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SCarlet RoAD
    Arm description
    		 Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gantenerumab
    Investigational medicinal product code
    Other name
    RO4909832
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Gantenerumab was administered as SC injection Q4W.

    Arm title
    		 Marguerite RoAD
    Arm description
    		 Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gantenerumab
    Investigational medicinal product code
    Other name
    RO4909832
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Gantenerumab was administered as SC injection Q4W.

    Number of subjects in period 1
    		SCarlet RoAD Marguerite RoAD
    Started
    59
    57
    Completed
    1
    0
    Not completed
    58
    57
         Consent withdrawn by subject
    9
    10
         Physician decision
    3
    1
         Adverse event, non-fatal
    3
    -
         Death
    2
    -
         Study terminated by sponsor
    30
    33
         Reason not specified
    2
    7
         Progressive disease
    9
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SCarlet RoAD
    Reporting group description
    		 Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks.

    Reporting group title
    Marguerite RoAD
    Reporting group description
    		 Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.

    Reporting group values
    		 SCarlet RoAD Marguerite RoAD Total
    Number of subjects
    		 59 57 116
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 78.0 ( 6.7 ) 75.2 ( 8.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 36 35 71
        Male
    		 23 22 45
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 9 4 13
        Not Hispanic or Latino
    		 50 53 103
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 0 13 13
        Black or African American
    		 0 1 1
        White
    		 56 42 98
        Unknown or Not Reported
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    SCarlet RoAD
    Reporting group description
    		 Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks.

    Reporting group title
    Marguerite RoAD
    Reporting group description
    		 Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.

    Primary: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab. Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    End point type
    Primary
    End point timeframe
    Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    59
    56
    Units: participants
        AE
    54
    49
        SAE
    11
    10
    No statistical analyses for this end point

    Primary: Number of Participants with Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Participants with Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [2]
    End point description
    C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Intensity of ideation, behavior, & attempts with actual/potential lethality were categories with binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation(SI) with Any Methods (Not Plan) without Intent to Act; Active SI with Some Intent to Act, without Specific Plan; Active SI with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal Ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0= no suicide risk present. Score of 1 or > 1= suicidal ideation/behavior. Number of participants with any suicidal ideation/behavior were reported. SE population was used. n= number analysed is number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), up to Week 104
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    56
    54
    Units: participants
        Baseline (n=56,54)
    3
    0
        Week 24 (n=52,44)
    2
    0
        Week 52 (n=48,38)
    1
    0
        Week 76 (n=37,32)
    0
    1
        Week 104 (n=30,0)
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab

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    End point title
    		 Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab [3]
    End point description
    Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    End point type
    Primary
    End point timeframe
    Up to Week 133
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    59
    56
    Units: participants
    3
    1
    No statistical analyses for this end point

    Primary: Number of Participants with Injection-Site Reactions

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    End point title
    		 Number of Participants with Injection-Site Reactions [4]
    End point description
    Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    End point type
    Primary
    End point timeframe
    Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    59
    56
    Units: participants
    14
    7
    No statistical analyses for this end point

    Primary: Number of Participants Who Discontinued Treatment due to AEs

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    End point title
    		 Number of Participants Who Discontinued Treatment due to AEs [5]
    End point description
    An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab. Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    End point type
    Primary
    End point timeframe
    Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    59
    56
    Units: participants
    3
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs

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    End point title
    		 Number of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs [6]
    End point description
    Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    End point type
    Primary
    End point timeframe
    Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    59
    56
    Units: participants
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) AEs

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    End point title
    		 Number of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) AEs [7]
    End point description
    Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    End point type
    Primary
    End point timeframe
    Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned.
    End point values
    		 SCarlet RoAD Marguerite RoAD
    Number of subjects analysed
    59
    56
    Units: participants
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
    Adverse event reporting additional description
    Safety evaluable population included all the participants who received at least one dose of gantenerumab.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Marguerite RoAD
    Reporting group description
    		 Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.

    Reporting group title
    SCarlet RoAD
    Reporting group description
    		 Participants enrolled from the OLE part of parent study WN25203, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.

    Serious adverse events
    		 Marguerite RoAD SCarlet RoAD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 56 (17.86%)
    11 / 59 (18.64%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer stage I
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 59 (3.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Gastrointestinal disorders
    Acute abdomen
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Neuropsychiatric symptoms
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Marguerite RoAD SCarlet RoAD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 56 (69.64%)
    43 / 59 (72.88%)
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 59 (0.00%)
         occurrences all number
    4
    0
    Rib fracture
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 59 (0.00%)
         occurrences all number
    3
    0
    Fall
         subjects affected / exposed
    8 / 56 (14.29%)
    13 / 59 (22.03%)
         occurrences all number
    15
    20
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 59 (6.78%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    7 / 56 (12.50%)
    14 / 59 (23.73%)
         occurrences all number
    34
    183
    Pyrexia
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 59 (1.69%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 59 (5.08%)
         occurrences all number
    5
    3
    Diarrhoea
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 59 (3.39%)
         occurrences all number
    5
    4
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 59 (5.08%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 59 (1.69%)
         occurrences all number
    5
    1
    Agitation
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 59 (8.47%)
         occurrences all number
    3
    6
    Anxiety
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 59 (6.78%)
         occurrences all number
    4
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 56 (8.93%)
    2 / 59 (3.39%)
         occurrences all number
    5
    2
    Arthralgia
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 59 (1.69%)
         occurrences all number
    5
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 56 (17.86%)
    13 / 59 (22.03%)
         occurrences all number
    10
    14
    Urinary tract infection
         subjects affected / exposed
    7 / 56 (12.50%)
    8 / 59 (13.56%)
         occurrences all number
    10
    12
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 59 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 59 (6.78%)
         occurrences all number
    0
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 59 (1.69%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2022
    Protocol was amended to allow participants who completed dosing visit (Week 104) to continue participation in the study for an additional 2 years. Changes to the protocol, along with a rationale for each change, are summarized below: - The study was accordingly divided into two parts. Part 1 reflected the initial study period of 2 years and Part 2 reflected the study period of additional 2 years beyond the initial 2 years because the safety profile combined with the potential benefit indicates that a longer period of treatment is justified. The protocol body was updated accordingly to clarify Part 1 from Part 2. Text from Part 1 was also updated from present to past tense to reflect the completion of Part 1, where applicable. - Sections were updated to reflect the recent study status in alignment with the Gantenerumab Investigator’s Brochure v17. - Benefit-risk assessment on concomitant administration of severe acute respiratory syndrome coronavirus 2 vaccines with gantenerumab was added to address a Health Authority request. - The sample size for Part 1 of the study was not available at the time of writing the protocol, as it was going to be determined by the number of participants who completed OLE part of Studies WN25203 and WN28745. As this number was determined. Section 3 was updated accordingly. - Section was revised to clarify the Medical Monitor’s responsibility to review and support participant cohort management and other protocol activities. Any reference to approval by the Medical Monitor with regards to medical decisions following enrollment was removed from the protocol. This means that the Principal Investigator (PI) may consult with the Medical Monitor/Sponsor for advice or clarification and may share risk factor information pertinent to the participant, but the medical decisions for the study participants are the responsibility of the PI.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    04 Jan 2023
    Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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