Effect of IVIG on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease
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|ClinicalTrials.gov Identifier: NCT03319810|
Recruitment Status : Completed
First Posted : October 24, 2017
Results First Posted : April 16, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Biological: Octagam 10%||Phase 2|
This is a single center, open label, proof of concept, out-patient study. Subjects will undergo Florbetapir PET and have retinal amyloid levels measured, receive an infusion of IVIG at 0.4 g/kg every 14 days for a total of five infusions, and repeat PET and retinal amyloid measures three months after the first infusion.
The study population will consist of male and female subjects diagnosed with mild cognitive impairment (MCI) due to Alzheimer disease (AD).
Estimated study duration:
The duration of each study subject is approximately 4 months, including one screening visit over a period of approximately 28 days, 5 days of infusions over a 2-month period of time, and a follow-up visit at 3 months after the first infusion.
Description of study drug:
Octagam is an FDA approved 10% human normal immunoglobulin solution ready for intravenous administration.
Study drug dosage:
The dose level of IVIG at 0.4 g/kg will be administered by IV infusion once every 14 days for two months.
Concomitant medications will be assessed at all study visits. Concomitant medications are prescribed or over-the-counter medications and should be consistent with the inclusion/exclusion criteria. Concomitant medication appropriate to the subject's condition may be prescribed during the course of the study with the exception of those listed above.
Routine vaccinations (i.e., flu vaccination) with commercially available therapeutics are permitted but must not be given within four weeks before or after the administration of the study drug.
Evaluations by visit:
Screening procedures at visit 1 will take place up to 28 days prior to Visit 2 (Day 1) dosing. Screening labs and assessments will be performed during the screening period. The first dose of study drug is administered on Day 1. Visits 2 through 6 have a ±1 day window and occur every 14 days over two months. The investigator will determine if a subject is suitable to continue following a missed infusion. Visit 7 has a ±7 day window.
All study screening data from Visit 1 including laboratory results must be reviewed for study eligibility prior to receiving first dose of study drug. Prior to infusion, a review of concomitant medications and AEs takes place. If the subject continues to be eligible for enrollment, the subject will be infused with study medication and will remain in the infusion clinic for at least 1 hour following the infusion for safety assessments on Visit 2 (Day 1), and 15 minutes for the subsequent visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single center, open label, proof of concept, out-patient study.|
|Masking:||None (Open Label)|
|Official Title:||Proof of Concept of the Effect of Intravenous Immunoglobulin on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease|
|Actual Study Start Date :||January 4, 2018|
|Actual Primary Completion Date :||July 19, 2018|
|Actual Study Completion Date :||July 19, 2018|
|Experimental: infusion of IVIG||
Biological: Octagam 10%
FDA approved human normal immunoglobulin solution ready for intravenous administration
- Change in Baseline Standard Uptake Ratio Values (SUVr) of Florbetapir PET at 3 Months [ Time Frame: Baseline to 3 months ]Amyloid deposition in the brain is thought to lead to the development of cognitive decline and conversion to AD. Each participant's amyloid burden can also be quantified through the computation of a Standard Uptake Value ratio (SUVr).
- Change in Baseline Retinal Amyloid Imaging (RAI) at 3 Months [ Time Frame: Baseline to 3 months ]This is a noninvasive imaging technique that can detect amyloid-beta deposition in the retinas of the eye.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319810
|United States, California|
|Sutter Neuroscience Medical Group|
|Sacramento, California, United States, 95816|
|Principal Investigator:||Shawn Kile, MD||Sutter Health|
|Study Director:||Carol Parise, PhD||Sutter Health|