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Effect of IVIG on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease

NCT03319810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-06-25

Study results available
· View outcomes & findings →

Summary

This is a proof of concept study to determine if changes in brain amyloid levels are evident three months after infusion of 0.4 g/kg of IVIG every 14 days x 5 infusions. Amyloid levels will be measured by Florbetapir PET and retinal scan.

Conditions

Interventions

BIOLOGICAL

Octagam 10%

FDA approved human normal immunoglobulin solution ready for intravenous administration

Sponsors & Collaborators

  • Sutter Health

    lead OTHER

Principal Investigators

  • Shawn Kile, MD · Sutter Health

  • Carol Parise, PhD · Sutter Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2018-07-19
Completion
2018-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03319810 on ClinicalTrials.gov