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Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment (MCI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shawn Kile, M.D., Sutter Health
ClinicalTrials.gov Identifier:
NCT01300728
First received: February 22, 2011
Last updated: March 1, 2016
Last verified: November 2015
Results First Received: August 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Mild Cognitive Impairment
Interventions: Drug: NewGam 10% IVIG
Other: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-two participants were randomized; however, 2 participants in the IVIG group did not complete the series of 5 infusions, and 1 placebo participant was excluded due to significant language symptoms which were a barrier to cognitive testing. This resulted having a data set consisting of a total of 49 subjects.

Reporting Groups
  Description
Intravenous Immunoglobulin (IVIG)

IVIG (NewGam 10%)at 0.4 g/kg

NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.

Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo.

Saline Solution

0.9% saline solution

Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio.


Participant Flow:   Overall Study
    Intravenous Immunoglobulin (IVIG)     Saline Solution  
STARTED     26     26  
COMPLETED     24     25  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 1  
Physician Decision                 1                 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.
No text entered.

Reporting Groups
  Description
Intravenous Immunoglobulin (IVIG)

IVIG (NewGam 10%)at 0.4 g/kg

NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.

Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo.

Saline Solution

0.9% saline solution

Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio.

Total Total of all reporting groups

Baseline Measures
    Intravenous Immunoglobulin (IVIG)     Saline Solution     Total  
Number of Participants  
[units: participants]
  24     25     49  
Age  
[units: years]
Mean (Standard Deviation)
  72.26  (7.91)     72.40  (7.36)     72.32  (7.56)  
Gender  
[units: participants]
     
Female     14     14     28  
Male     10     11     21  
Mean Cognitive Performance [1]
[units: units on a scale]
Mean (Standard Deviation)
     
MMSE     26.75  (2.15)     26.44  (2.6)     26.59  (2.37)  
ADAS-cog     10.63  (4.23)     10.29  (5.68)     10.46  (4.97)  
CDR_SB     1.96  (0.95)     1.58  (0.90)     1.78  (0.94)  
[1]

12 month cognitive performance in treatment (IVIG/placebo) is measured by:

  • Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)

    • Scale from 0 to 85 (0 is best cognitive performance)
    • Score is the sum of 12 sub-scales.
  • Mini Mental State Exam (MMSE)

    • Scale from 0 to 30 (30 is best cognitive performance)
    • Score is the sum of 11 sub-scales.
  • Clinical Dementia Rating - Sum of Boxes (CDR-SB)

    • Scale is 0 to 18 (0 is best cognitive performance)
    • Score is the sum of 6 sub-scales



  Outcome Measures
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1.  Primary:   Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI   [ Time Frame: Baseline, 12, and 24 month MRI evaluation ]

2.  Secondary:   Number of Participants Who Converted From Amnestic Mild Cognitive Impairment (a-MCI) to Alzheimer Disease (AD)   [ Time Frame: Baseline to 24 months ]

3.  Secondary:   Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature   [ Time Frame: Baseline to 24 months following infusion ]

4.  Secondary:   Mean Cognitive Performance at 12 Months   [ Time Frame: 12 months ]

5.  Secondary:   Mean Cognitive Performance at 24 Months   [ Time Frame: 24 month ]


  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
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  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: Shawn Kile, MD
Organization: Sutter Neurology Medical Group
phone: (916) 454-6850
e-mail: KileS@sutterhealth.org


Publications of Results:
Other Publications:

Responsible Party: Shawn Kile, M.D., Sutter Health
ClinicalTrials.gov Identifier: NCT01300728     History of Changes
Other Study ID Numbers: IVIG-KILE-032010
Study First Received: February 22, 2011
Results First Received: August 8, 2015
Last Updated: March 1, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board