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Immunoglobulin

intravenous immunoglobulin (IVIG) for Mild Cognitive Impairment (MCI Trial)

Phase 2
Waitlist Available
Led By Shawn Kile, M.D.
Research Sponsored by Sutter Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mini-Mental State Examination (MMSE) score of 24-30, inclusive.
Age from 50 to < 85 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12, and 24 month mri evaluation
Awards & highlights

MCI Trial Summary

Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease. This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over 24 months after the first infusion. This study will also document conversion from MCI to Alzheimer's Disease.

Eligible Conditions
  • Mild Cognitive Impairment

MCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12, and 24 month mri evaluation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12, and 24 month mri evaluation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI
Secondary outcome measures
Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature
Mean Cognitive Performance at 12 Months
Mean Cognitive Performance at 24 Months
+1 more

Side effects data

From 2020 Phase 2 trial • 52 Patients • NCT01300728
4%
Low grade fever
4%
Nausea
4%
Insomnia
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Immunoglobulin (IVIG)
Saline Solution

MCI Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: intravenous immunoglobulin (IVIG)Experimental Treatment1 Intervention
IVIG (NewGam 10%)at 0.4 g/kg
Group II: Saline solutionPlacebo Group1 Intervention
0.9% saline solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Find a Location

Who is running the clinical trial?

Sutter HealthLead Sponsor
21 Previous Clinical Trials
156,848 Total Patients Enrolled
Shawn Kile, M.D.Principal InvestigatorSutter Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025