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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 10, 2008 | ||||
| Last Updated Date | March 9, 2011 | ||||
| Start Date ICMJE | December 2008 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To measure the change in amyloid beta peptide concentration of the blood plasma from immediately prior to the last IVIG infusion calculated over 2 or 4 weeks. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00812565 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To measure changes from baseline in MRI, PET scan, neuropsychometric testing results, autoantibody concentrations in the blood and in CSF, CSF tau and pTau concentrations. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Octagam 10% on the Treatment of Mild to Moderate Alzheimer's Patients | ||||
| Official Title ICMJE | Prospective 24-week, Double-blind, Randomized, Multicenter, Placebo-controlled Study Evaluating Safety and Change in Surrogate Parameters After Treatment With Increasing Dosages of Intravenous Immunoglobulin (IGIV) in Mild to Moderate Alzheimer's Disease | ||||
| Brief Summary | To evaluate the effect of 6 or 12 infusions of differenct dosages of IVIG 10% at regular study visit intervals on the reduction of amyloid beta peptide antibody in the CSF and the increase in the blood plasma in patients with mild to moderate Alzheimer's disease. |
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| Detailed Description | To evaluate the effect of 12 infusions of 0.1 g/kg, 0.25 g/kg or 0.4 g/kg IGIV 10% at a 2-week +/- 3 days interval or 6 infusions of 0.2 g/kg, 0.5 g/kg or 0.8 g/kg body weight IGIV 10% at a 4-week +/- 5 days interval on the reduction of +/- in the CSF and the increase in the blood plasma in mild to moderate AD patients. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase II | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Alzheimer's Disease | ||||
| Intervention ICMJE | Biological: IVIG
Octagam 10%
Other Name: IVIG |
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| Study Arms |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 58 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00812565 | ||||
| Other Study ID Numbers ICMJE | GAM10-04 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Heather Almonte, Octapharma AG | ||||
| Study Sponsor ICMJE | Octapharma | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Octapharma | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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