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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00812565
First received: November 10, 2008
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: December 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Placebo
Biological: octagam 10%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Qualified patients meeting all inclusion exclusion criteria and providing informed consent were enrolled into the trial.

Reporting Groups
  Description
Placebo Every 2 Weeks Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
0.1 g/kg Octagam 10% Every 2 Weeks Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
0.25 g/kg Octagam 10% Every 2 Weeks Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
0.4 g/kg Octagam 10% Every 2 Weeks Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Placebo Every 4 Weeks Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
0.2 g/kg Octagam 10% Every 4 Weeks Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
0.5 g/kg Octagam 10% Every 4 Weeks Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
0.8 g/kg Octagam 10% Every 4 Weeks Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

Participant Flow:   Overall Study
    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     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  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Every 2 Weeks Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
0.1 g/kg Octagam 10% Every 2 Weeks Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
0.25 g/kg Octagam 10% Every 2 Weeks Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
0.4 g/kg Octagam 10% Every 2 Weeks Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
Placebo Every 4 Weeks Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
0.2 g/kg Octagam 10% Every 4 Weeks Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
0.5 g/kg Octagam 10% Every 4 Weeks Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
0.8 g/kg Octagam 10% Every 4 Weeks Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Total Total of all reporting groups

Baseline Measures
    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 Participants  
[units: participants]
  7     6     7     7     7     6     8     7     55  
Age  
[units: Years]
Mean ± Standard Deviation
  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  
Gender  
[units: participants]
                 
Female     4     1     3     3     5     2     3     3     24  
Male     3     5     4     4     2     4     5     4     31  



  Outcome Measures
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1.  Primary:   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   [ 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 ]

2.  Secondary:   Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)   [ Time Frame: Baseline to Week 24 ]

3.  Secondary:   Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   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   [ 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 ]

5.  Secondary:   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   [ 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 ]

6.  Secondary:   Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion   [ 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 ]

7.  Secondary:   Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion   [ 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 ]

8.  Secondary:   Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion   [ 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 ]

9.  Secondary:   Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24   [ Time Frame: Baseline to Week 24 ]

10.  Secondary:   Change From Baseline in the Alzheimer’s Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24   [ Time Frame: Baseline to Week 24 ]

11.  Secondary:   Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24   [ Time Frame: Baseline to Week 24 ]

12.  Secondary:   Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24   [ Time Frame: Baseline to Week 24 ]

13.  Secondary:   Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24   [ Time Frame: Screening to Week 24 ]

14.  Secondary:   Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24   [ Time Frame: Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small numbers of patients per treatment group (between 5 and 8) and variable total Aβ levels over time.


  More Information
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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
e-mail: michael.eppolito@octapharma.com


No publications provided by Octapharma

Publications automatically indexed to this study:

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00812565     History of Changes
Other Study ID Numbers: GAM10-04
Study First Received: November 10, 2008
Results First Received: December 2, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration