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Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00812565
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Octapharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Placebo
Biological: octagam 10%
Enrollment 58
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 Details Qualified patients meeting all inclusion exclusion criteria and providing informed consent were enrolled into the trial.
Arm/Group Title 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
Hide Arm/Group Description Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions). Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions). Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions). Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions). Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions). Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Period Title: Overall Study
Started 8 7 7 7 7 7 8 7
Completed 5 6 7 5 6 6 8 6
Not Completed 3 1 0 2 1 1 0 1
Reason Not Completed
Did Not Receive Study Medication             1             1             0             0             0             0             0             0
Adverse Event             0             0             0             2             0             0             0             1
Did Not Come to Study Visit             1             0             0             0             0             0             0             0
Withdrawal of Consent             1             0             0             0             1             0             0             0
Reason Not Specified             0             0             0             0             0             1             0             0
Arm/Group Title 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
Hide Arm/Group Description Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions). Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions). Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions). Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions). Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions). Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions). Total of all reporting groups
Overall Number of Baseline Participants 7 6 7 7 7 6 8 7 55
Hide Baseline Analysis Population Description
Full analysis set: All randomized patients who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 7 participants 7 participants 7 participants 6 participants 8 participants 7 participants 55 participants
72.6  (9.2) 66.8  (5.5) 68.3  (4.2) 72.9  (5.0) 71.4  (11.8) 74.8  (5.5) 65.9  (10.2) 68.4  (8.6) 70.0  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 7 participants 7 participants 7 participants 6 participants 8 participants 7 participants 55 participants
Female
4
  57.1%
1
  16.7%
3
  42.9%
3
  42.9%
5
  71.4%
2
  33.3%
3
  37.5%
3
  42.9%
24
  43.6%
Male
3
  42.9%
5
  83.3%
4
  57.1%
4
  57.1%
2
  28.6%
4
  66.7%
5
  62.5%
4
  57.1%
31
  56.4%
1.Primary Outcome
Title 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
Hide 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).
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: (pg/mL)*days
161.20  (93.90) -245.67  (747.58) -122.50  (478.31) -39.10  (172.72) 510.92  (2395.80) -83.67  (957.69) -755.38  (2232.87) -262.92  (671.37)
2.Secondary Outcome
Title Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)
Hide Description Samples for determining Aβ1-40 and Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 6 6 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
Aβ1-40 27.1  (40.2) 5.5  (64.5) -0.3  (22.1) -6.5  (61.4) -6.0  (23.8) -20.3  (29.2) 15.7  (29.7) -30.5  (42.3)
Aβ1-42 4.1  (3.8) -2.3  (7.8) -4.5  (6.3) -2.7  (7.6) -2.0  (4.8) -3.5  (5.8) -0.1  (4.4) -7.0  (6.2)
3.Secondary Outcome
Title Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)
Hide Description Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 7 6 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: RTU
109.7  (284.8) 74.3  (35.0) 163.9  (136.6) 310.2  (193.0) -56.3  (58.3) 96.7  (133.7) 256.6  (214.1) 501.3  (514.6)
4.Secondary Outcome
Title Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion
Hide 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 Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: (pg/mL)*days
40.70  (48.54) -8.92  (61.71) -53.94  (61.59) -17.00  (23.67) 50.13  (233.87) -8.98  (213.29) -191.58  (456.83) -64.75  (148.29)
5.Secondary Outcome
Title Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion
Hide 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 anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: RTU*days
2829.0  (3957.9) 358.3  (435.8) 1862.5  (1470.9) 2189.6  (2289.3) 196.6  (1023.0) 849.4  (2313.6) 6350.8  (3464.9) 8494.9  (2292.4)
6.Secondary Outcome
Title Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion
Hide Description Samples for determining Aβ1-40 and Aβ1-42 in cerebral spinal fluid were processed at a central laboratory using a commercially available kit from Meso Scale Discovery (MSD 96-Well Multi-Spot Human/Rodent (4G8) Abeta Triplex Ultra-Sensitive Assay; Rockville, MD, USA).
Time Frame Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
Aβ1-40 939.4  (1670.8) 266.7  (996.0) 10.6  (1104.0) -147.0  (1067.9) 42.0  (874.0) 561.7  (1195.5) 403.9  (588.1) 642.2  (1171.3)
Aβ1-42 32.4  (67.0) -8.7  (38.2) 9.7  (54.7) 4.0  (40.3) -5.2  (36.3) 18.8  (40.3) 10.5  (40.9) 24.7  (43.2)
7.Secondary Outcome
Title Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion
Hide Description Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.
Time Frame Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: RTU
0.38  (3.72) 0.22  (1.83) 1.86  (1.93) -0.78  (1.64) 0.15  (0.29) 0.40  (1.43) 1.12  (1.48) 0.74  (2.32)
8.Secondary Outcome
Title Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion
Hide Description Samples for determining tau and phosphorylated tau in cerebral spinal fluid were processed at a central laboratory using commercially available kits from Innogenetics NV (INNOTEST® hTau Ag, INNOTEST PHOSPHO-TAU (181P); Gent, Belgium). To measure phosphorylated tau, tau phosphorylated at threonine 181 (pTau181) was determined.
Time Frame Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 6 6 8 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
Tau 17.4  (38.6) 209.3  (416.0) -3.4  (35.6) -7.8  (51.3) -33.2  (69.7) -141.8  (419.5) 1.3  (86.7) 131.3  (301.0)
Phosphorylated tau 0.60  (7.50) -3.17  (14.66) 0.43  (3.60) 2.60  (4.98) -1.33  (10.05) 3.33  (21.23) -2.50  (8.62) 10.17  (19.28)
9.Secondary Outcome
Title Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24
Hide Description The MMSE test contains 30 questions that assess 8 cognitive domains (orientation to time, orientation to place, registration, attention and calculation, recall, language, repetition, and complex commands). The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 (severe impairment) to 30 (no impairment), with a higher score indicating a better mental status. A positive change score indicates improvement.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 7 6 7 6 8 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=6,6,7,5,7,6,8,7) 1.5  (2.1) -2.3  (3.5) -0.6  (3.0) -2.0  (3.1) -0.7  (3.0) -1.2  (2.3) -0.3  (2.8) -0.9  (2.4)
Week 24 (n=7,6,7,6,6,6,8,6) -0.7  (3.0) -2.2  (4.4) 0.6  (2.5) -1.7  (2.3) -1.8  (5.5) -3.2  (3.3) -1.8  (1.8) -1.5  (3.1)
10.Secondary Outcome
Title Change From Baseline in the Alzheimer’s Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24
Hide Description The ADAS cog consists of 11 items that assess cognitive areas that are often impaired in Alzheimer’s disease, specifically learning (word list), naming (objects), following commands (1 to 5 elements), ideational praxis (mail a letter), constructional praxis (copy 4 figures), orientation (person, time and place), recognition memory (from a second word list), and remembering test instructions (from the recognition subtest). The test includes 3 additional subjective scales that assess spoken language ability, word finding difficulty, and comprehension. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 70 with a higher score indicating greater cognitive impairment. A negative change score indicates improvement.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 7 6 7 6 8 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=6,6,7,5,7,6,8,7) 1.11  (4.10) 0.94  (7.27) -0.86  (4.75) -0.07  (4.43) 1.52  (5.67) 3.67  (3.85) 1.54  (6.63) 2.28  (5.06)
Week 24 (n=7,6,7,6,5,6,8,6) -0.62  (3.86) 2.06  (3.32) -2.14  (4.41) 3.67  (4.85) 0.93  (3.29) 4.17  (4.85) 3.00  (9.37) 1.89  (8.71)
11.Secondary Outcome
Title Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24
Hide Description The ADAS-ADL consists of 23 questions that measure the ability of a person to perform basic activities of daily living, such as eating, walking, bathing, grooming, and dressing. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 78 with a lower score indicating more impaired ability. A positive change score indicates improvement.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 7 6 7 6 8 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=6,6,7,5,7,6,8,7) 6.7  (4.0) 0.0  (5.4) 1.7  (2.8) -1.2  (3.5) -0.6  (8.5) -8.2  (11.8) 1.8  (5.0) -1.9  (3.5)
Week 24 (n=7,6,7,6,5,6,8,6) 1.9  (5.0) -1.5  (5.2) -4.1  (6.6) -6.5  (9.7) -1.8  (6.0) -4.3  (14.4) 1.5  (8.2) -1.2  (3.3)
12.Secondary Outcome
Title Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24
Hide Description A semi-structured interview was conducted by a physician, neuropsychologist, psychometrician, or certified study coordinator with the patient and a caregiver. Based on the results of the interview, the patient was rated on 6 domains of cognition and function: Memory, orientation, judgment/problem solving, community activities, home and hobbies, and personal care. Each domain is rated from 0 = no dementia; 0.5 = questionable dementia, mild cognitive impairment; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. The total score ranges from 0 to 18 with a higher score indicating more dementia. A negative change score indicates improvement.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 7 6 7 6 8 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=6,6,7,5,7,6,8,7) -0.67  (1.08) -0.25  (0.76) 0.21  (0.86) 0.60  (0.89) -0.36  (1.38) 0.42  (1.36) 0.50  (1.46) 0.21  (1.52)
Week 24 (n=7,6,7,6,5,6,8,6) -0.57  (1.57) 0.92  (2.15) 0.14  (1.28) 1.25  (1.97) -1.50  (2.55) 0.83  (1.44) 0.44  (1.92) 0.58  (1.66)
13.Secondary Outcome
Title Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24
Hide Description The volume of the whole brain and of the left and right hippocampus was measured using high-resolution structural coronal 3D heavily T1-weighted gradient-echo sequence magnetic resonance imaging. All evaluations were done centrally by Professor Frederik Barkhof at the Image Analysis Centre, VU Medical Center, Amsterdam, Netherlands. A negative change score indicates loss of brain volume.
Time Frame Screening to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 5 6 7 5 7 6 8 7
Mean (Standard Deviation)
Unit of Measure: cm^3
Whole brain - Week 12 (n=5,5,7,4,7,6,7,7) -0.112  (0.738) -0.548  (1.001) -0.709  (1.026) -1.833  (2.001) 0.533  (0.481) -0.528  (1.873) -0.177  (1.219) -1.109  (0.731)
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7) -4.3  (2.7) -3.1  (3.1) -2.4  (1.7) -1.8  (4.2) -2.8  (2.6) -2.8  (3.9) -4.8  (5.0) -2.2  (3.7)
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7) -3.8  (2.7) -2.6  (3.8) -3.6  (2.6) -3.0  (2.4) -4.8  (4.2) -1.8  (1.6) -1.5  (3.6) -4.9  (3.2)
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6) -1.403  (0.978) -1.978  (0.798) -1.488  (0.726) -1.390  (1.678) -0.875  (0.780) -1.363  (1.752) -1.096  (1.004) -1.583  (1.070)
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6) -7.6  (3.8) -6.6  (3.0) -6.0  (2.8) -5.2  (4.1) -6.0  (5.0) -7.4  (4.3) -6.9  (7.7) -6.2  (3.7)
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6) -7.3  (1.2) -4.4  (4.7) -6.3  (5.6) -4.5  (7.1) -5.1  (4.5) -5.3  (2.4) -6.5  (4.6) -8.2  (5.0)
14.Secondary Outcome
Title Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24
Hide Description Cerebral glucose metabolism was measured in validated 3 dimensional statistic surface projection analysis (Cortex ID®, GE Healthcare), transversal/coronal/sagittal-slice analysis (HERMES BRASS), and voxel-wise whole brain analysis (SPM5) using [18F]fluorodeoxyglucose positron emission tomography.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 7 6 6 6 6 7 8 7
Mean (Standard Deviation)
Unit of Measure: µCi/mL
Right hippocampus - Baseline 0.83  (0.06) 0.81  (0.06) 0.81  (0.06) 0.83  (0.06) 0.81  (0.08) 0.88  (0.03) 0.82  (0.08) 0.81  (0.04)
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6) 0.84  (0.07) 0.83  (0.07) 0.83  (0.06) 0.81  (0.02) 0.82  (0.07) 0.87  (0.04) 0.84  (0.07) 0.82  (0.03)
Left hippocampus - Baseline 0.79  (0.05) 0.77  (0.06) 0.80  (0.07) 0.81  (0.05) 0.81  (0.07) 0.84  (0.05) 0.80  (0.06) 0.77  (0.04)
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6) 0.80  (0.03) 0.78  (0.05) 0.84  (0.09) 0.80  (0.07) 0.81  (0.08) 0.84  (0.05) 0.81  (0.05) 0.79  (0.05)
Time Frame Adverse events were monitored throughout the entire study period, starting from the baseline visit until the final study visit.
Adverse Event Reporting Description Safety set: All randomized participants who received at least 1 infusion of study medication.
 
Arm/Group Title 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
Hide Arm/Group Description Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions). Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions). Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions). Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions). Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions). Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   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%) 
Gastrointestinal disorders                 
Gastral antral vascular ectasia  1  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%) 
Nausea  1  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%) 
Vomiting  1  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%) 
Nervous system disorders                 
Cerebral infarction  1  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%) 
Convulsion  1  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%) 
Dementia Alzheimer's Type  1  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%) 
Psychiatric disorders                 
Delirium  1  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%) 
Aggression  1  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%) 
Surgical and medical procedures                 
Knee arthroplasty  1  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%) 
Spinal laminectomy  1  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%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   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%) 
Blood and lymphatic system disorders                 
Anemia  1  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%) 
Iron deficiency anemia  1  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%) 
Lymphadenopathy  1  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%) 
Cardiac disorders                 
Atrial fibrillation  1  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%) 
Ear and labyrinth disorders                 
Hearing impaired  1  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%) 
Eye disorders                 
Glaucoma  1  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%) 
Gastrointestinal disorders                 
Colitis microscopic  1  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%) 
Colonic polyp  1  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%) 
Dyspepsia  1  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%) 
Gastrointestinal pain  1  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%) 
Hiatus hernia  1  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%) 
Vomiting  1  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%) 
General disorders                 
Chills  1  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%) 
Fatigue  1  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%) 
Influenza like illness  1  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%) 
Infusion site extravasation  1  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%) 
Pyrexia  1  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%) 
Submandibular mass  1  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%) 
Infections and infestations                 
Bronchitis  1  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%) 
Gastroenteritis  1  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%) 
Tooth abscess  1  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%) 
Tooth infection  1  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%) 
Upper respiratory tract infection  1  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%) 
Urinary tract infection  1  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%) 
Injury, poisoning and procedural complications                 
Anxiety postoperative  1  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%) 
Contusion  1  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%) 
Fall  1  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%) 
Periorbital haematoma  1  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%) 
Post lumbar puncture syndrome  1  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%) 
Post procedural constipation  1  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%) 
Post procedural haemorrhage  1  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%) 
Procedural headache  1  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%) 
Procedural hypertension  1  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%) 
Procedural pain  1  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%) 
Investigations                 
Aspartate aminotransferase increased  1  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%) 
Blood creatine phosphokinase increased  1  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%) 
Blood iron decreased  1  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%) 
Blood lactate dehydrogenase increased  1  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%) 
Blood magnesium decreased  1  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%) 
Blood potassium decreased  1  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%) 
Blood pressure decreased  1  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%) 
CSF white blood cell count positive  1  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%) 
Weight decreased  1  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%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  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%) 
Muscle spasms  1  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%) 
Rotator cuff syndrome  1  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%) 
Nervous system disorders                 
Cerebral haemorrhage  1  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%) 
Dizziness  1  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%) 
Essential tremor  1  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%) 
Headache  1  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%) 
Hypertonia  1  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%) 
Hypoaesthesia  1  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%) 
Hyporeflexia  1  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%) 
Paraesthesia  1  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%) 
Tremor  1  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%) 
Psychiatric disorders                 
Agitation  1  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%) 
Confusional state  1  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%) 
Depression  1  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%) 
Insomnia  1  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%) 
Renal and urinary disorders                 
Haematuria  1  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%) 
Respiratory, thoracic and mediastinal disorders                 
Respiratory tract congestion  1  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%) 
Rhinorrhoea  1  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%) 
Skin and subcutaneous tissue disorders                 
Actinic keratosis  1  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%) 
Dermatitis contact  1  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%) 
Ecchymosis  1  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%) 
Hyperkeratosis  1  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%) 
Pruritis  1  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%) 
Vascular disorders                 
Blood pressure fluctuation  1  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%) 
Hypertension  1  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%) 
Hypotension  1  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%) 
Vasoconstriction  1  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%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Small numbers of patients per treatment group (between 5 and 8) and variable total Aβ levels over time.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine
Organization: Octapharma USA
Phone: 201-604-1155
Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00812565     History of Changes
Other Study ID Numbers: GAM10-04
First Submitted: November 10, 2008
First Posted: December 22, 2008
Results First Submitted: December 2, 2013
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014