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    Clinical Trial Results:
    Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer’s type under treatment with increasing dosages of intravenous immunoglobulin (octagam® 10%)

    Summary
    EudraCT number
    		 2007-007134-19
    Trial protocol
    		 DE  
    Global end of trial date
    21 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2017
    First version publication date
    04 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GAM10-04
    Additional study identifiers
    ISRCTN number
    		 ISRCTN64846759
    US NCT number
    		 NCT00812565
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Octapharma AG
    Sponsor organisation address
    Seidenstrasse 2, Lachen, Switzerland, CH-8853
    Public contact
    Clinical Research and Development Octapharma Pharmazeutica Produktionsgesellschaft m.b.H, Octapharma Pharmazeutica Produktionsgesellschaft m.b.H, +43 1 61032-0,
    Scientific contact
    Clinical Research and Development Octapharma Pharmazeutica Produktionsgesellschaft m.b.H, Octapharma Pharmazeutica Produktionsgesellschaft m.b.H, +43 1 61032-0,
    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
    27 Nov 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the decrease of Aβ in the CNS and the increase in blood plasma, thereby corroborating the assumed primary mechanism of action of IVIG in AD patients, namely the interference with the pathomechanism for AD ("amyloid cascade hypothesis").
    Protection of trial subjects
    This trial was conducted in accordance to the principles of GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs, safety labs, vital signs and physical/neurological examinations, safety MRI.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    United States: 37
    Worldwide total number of subjects
    55
    EEA total number of subjects
    18
    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)
    14
    From 65 to 84 years
    40
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first patient was enrolled February 2, 2009. The last patient study visit was September 21, 2010. Patients were enrolled in this study from a variety of settings including private practice clinics and hospitals. There were 12 study sites, 5 in Germany and 7 in the United States.

    Pre-assignment
    Screening details
    		 Qualified patients meeting all inclusion exclusion criteria and providing informed consent were enrolled into the trial.

    Period 1
    Period 1 title
    Full Analyses Set
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Every 2 Weeks
    Arm description
    		 Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 0.1 g/kg Octagam 10% Every 2 Weeks
    Arm description
    		 Participants received 0.1 g/kg Octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 0.25 g/kg Octagam 10% Every 2 Weeks
    Arm description
    		 Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 0.4 g/kg Octagam 10% Every 2 Weeks
    Arm description
    		 Participants received of 0.4 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 Placebo Every 4 Weeks
    Arm description
    		 Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Arm title
    		 0.2 g/kg Octagam 10% Every 4 Weeks
    Arm description
    		 Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Arm title
    		 0.5 g/kg Octagam 10% Every 4 Weeks
    Arm description
    		 Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.5 g/kg Octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Arm title
    		 0.8 g/kg Octagam 10% Every 4 Weeks
    Arm description
    		 Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Number of subjects in period 1
    		Placebo Every 2 Weeks 0.1 g/kg Octagam 10% Every 2 Weeks 0.25 g/kg Octagam 10% Every 2 Weeks 0.4 g/kg Octagam 10% Every 2 Weeks Placebo Every 4 Weeks 0.2 g/kg Octagam 10% Every 4 Weeks 0.5 g/kg Octagam 10% Every 4 Weeks 0.8 g/kg Octagam 10% Every 4 Weeks
    Started
    7
    6
    7
    7
    7
    6
    8
    7
    Completed
    7
    6
    7
    7
    7
    6
    8
    7
    Period 2
    Period 2 title
    Completed
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Every 2 Weeks
    Arm description
    		 Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 0.1 g/kg Octagam 10% Every 2 Weeks
    Arm description
    		 Participants received 0.1 g/kg Octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 0.25 g/kg Octagam 10% Every 2 Weeks
    Arm description
    		 Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 0.4 g/kg Octagam 10% Every 2 Weeks
    Arm description
    		 Participants received of 0.4 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Arm title
    		 Placebo Every 4 Weeks
    Arm description
    		 Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Arm title
    		 0.2 g/kg Octagam 10% Every 4 Weeks
    Arm description
    		 Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Arm title
    		 0.5 g/kg Octagam 10% Every 4 Weeks
    Arm description
    		 Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.5 g/kg Octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Arm title
    		 0.8 g/kg Octagam 10% Every 4 Weeks
    Arm description
    		 Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%, human normal immunoglobulin solution ready for intravenous administration
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Number of subjects in period 2
    		Placebo Every 2 Weeks 0.1 g/kg Octagam 10% Every 2 Weeks 0.25 g/kg Octagam 10% Every 2 Weeks 0.4 g/kg Octagam 10% Every 2 Weeks Placebo Every 4 Weeks 0.2 g/kg Octagam 10% Every 4 Weeks 0.5 g/kg Octagam 10% Every 4 Weeks 0.8 g/kg Octagam 10% Every 4 Weeks
    Started
    7
    6
    7
    7
    7
    6
    8
    7
    Completed
    5
    6
    7
    5
    6
    6
    8
    6
    Not completed
    2
    0
    0
    2
    1
    0
    0
    1
         Consent withdrawn by subject
    1
    -
    -
    -
    1
    -
    -
    -
         Adverse Event
    -
    -
    -
    2
    -
    -
    -
    1
         Did Not Come To Study Visit
    1
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Every 2 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.1 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.1 g/kg Octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.25 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.4 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received of 0.4 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    Placebo Every 4 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.2 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.5 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.8 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group values
    		 Placebo Every 2 Weeks 0.1 g/kg Octagam 10% Every 2 Weeks 0.25 g/kg Octagam 10% Every 2 Weeks 0.4 g/kg Octagam 10% Every 2 Weeks Placebo Every 4 Weeks 0.2 g/kg Octagam 10% Every 4 Weeks 0.5 g/kg Octagam 10% Every 4 Weeks 0.8 g/kg Octagam 10% Every 4 Weeks Total
    Number of subjects
    		 7 6 7 7 7 6 8 7 55
    Age categorical
    Units: Subjects
        From 51-86 years
    		 7 6 7 7 7 6 8 7 55
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.57 ( 9.24 ) 66.83 ( 5.53 ) 68.29 ( 4.15 ) 72.86 ( 5.01 ) 71.43 ( 11.76 ) 74.83 ( 5.46 ) 65.88 ( 10.19 ) 68.43 ( 8.62 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 1 3 3 5 2 3 3 24
        Male
    		 3 5 4 4 2 4 5 4 31

    End points

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    End points reporting groups
    Reporting group title
    Placebo Every 2 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.1 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.1 g/kg Octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.25 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.4 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received of 0.4 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    Placebo Every 4 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.2 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.5 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.8 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
    Reporting group title
    Placebo Every 2 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.1 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.1 g/kg Octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.25 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.4 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received of 0.4 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    Placebo Every 4 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.2 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.5 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.8 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Primary: Change in the Area Under the Curve (AUC) of Plasma Aβ1-40 in the 2 or 4 weeks after the last treatment infusion from the trough level prior to the last treatment infusion

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    End point title
    		 Change in the Area Under the Curve (AUC) of Plasma Aβ1-40 in the 2 or 4 weeks after the last treatment infusion from the trough level prior to the last treatment infusion [1]
    End point description
    For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).
    End point type
    Primary
    End point timeframe
    Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks
    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: Results are provided as Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion
    End point values
    		 Placebo Every 2 Weeks 0.1 g/kg Octagam 10% Every 2 Weeks 0.25 g/kg Octagam 10% Every 2 Weeks 0.4 g/kg Octagam 10% Every 2 Weeks Placebo Every 4 Weeks 0.2 g/kg Octagam 10% Every 4 Weeks 0.5 g/kg Octagam 10% Every 4 Weeks 0.8 g/kg Octagam 10% Every 4 Weeks
    Number of subjects analysed
    5
    6
    7
    5
    6
    6
    8
    6
    Units: (pg/mL)*days]
        arithmetic mean (standard deviation)
    161.2 ( 93.9 )
    -245.67 ( 747.58 )
    -122.5 ( 478.31 )
    -39.1 ( 172.72 )
    510.92 ( 2395.8 )
    -83.67 ( 957.69 )
    -755.38 ( 2232.87 )
    -262.92 ( 671.37 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit.
    Adverse event reporting additional description
    Safety set: All randomized participants who received at least 1 infusion of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Placebo Every 2 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.1 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.1 g/kg Octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.25 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received 0.25 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    0.4 g/kg Octagam 10% Every 2 Weeks
    Reporting group description
    		 Participants received of 0.4 g/kg Octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).

    Reporting group title
    Placebo Every 4 Weeks
    Reporting group description
    		 Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.2 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.5 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Reporting group title
    0.8 g/kg Octagam 10% Every 4 Weeks
    Reporting group description
    		 Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

    Serious adverse events
    		 Placebo Every 2 Weeks 0.1 g/kg Octagam 10% Every 2 Weeks 0.25 g/kg Octagam 10% Every 2 Weeks 0.4 g/kg Octagam 10% Every 2 Weeks Placebo Every 4 Weeks 0.2 g/kg Octagam 10% Every 4 Weeks 0.5 g/kg Octagam 10% Every 4 Weeks 0.8 g/kg Octagam 10% Every 4 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Knee arthroplasty
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal laminectomy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric antral vascular ectasia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Every 2 Weeks 0.1 g/kg Octagam 10% Every 2 Weeks 0.25 g/kg Octagam 10% Every 2 Weeks 0.4 g/kg Octagam 10% Every 2 Weeks Placebo Every 4 Weeks 0.2 g/kg Octagam 10% Every 4 Weeks 0.5 g/kg Octagam 10% Every 4 Weeks 0.8 g/kg Octagam 10% Every 4 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    4 / 6 (66.67%)
    5 / 7 (71.43%)
    3 / 7 (42.86%)
    3 / 7 (42.86%)
    4 / 7 (57.14%)
    4 / 8 (50.00%)
    4 / 7 (57.14%)
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Vasoconstriction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Submandibular mass
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Blood iron decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Blood magnesium decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    CSF white blood cell count positive
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Anxiety postoperative
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    Periorbital haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Post procedural constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Procedural headache
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Procedural hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    1
    1
    Dizziness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    Essential tremor
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    1
    0
    Hypertonia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    Hyporeflexia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Colitis microscopic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Colonic polyp
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2009
    Amendment 1 (global, dated 10 June 2009): The changes were a result of issues encountered during the initial conduct of the trial that identified protocol requirements that were impractical and/or unnecessary for the study conduct. Other changes were administrative corrections or clarification of existing language. The specified changes referred to numbers of sites per country, time windows, sample collection and laboratory procedures and to the procedure of obtaining informed consent.
    07 Oct 2009
    Some mistakes/inconsistencies made in protocol version 2.3 were corrected. The specified changes referred to the numbers of sites per country and time windows.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Small numbers of patients per treatment group (between 5 and 8) and variable total Aβ levels over time.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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