Trial Outcomes & Findings for Effect of IVIG on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease (NCT NCT03319810)

NCT ID: NCT03319810

Last Updated: 2019-06-25

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Infusion of IVIG Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infusion of IVIG n=5 Participants Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
Age, Continuous	74.30 years STANDARD_DEVIATION 5.27 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Standard Uptake Value Ratio (SUVr)	1.57 standard uptake value ratio STANDARD_DEVIATION 0.16 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Outcome measures

Outcome measures
Measure	Infusion of IVIG n=5 Participants 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	-3.83 standard uptake value ratio Standard Deviation 2.84

PRIMARY outcome

Timeframe: Baseline to 3 months

This is a noninvasive imaging technique that can detect amyloid-beta deposition in the retinas of the eye.

Outcome measures

Outcome measures
Measure	Infusion of IVIG n=5 Participants Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
Change in Baseline Retinal Amyloid Imaging (RAI) at 3 Months Right Eye	-33.00 autofluorescent spot count Standard Deviation 68.52
Change in Baseline Retinal Amyloid Imaging (RAI) at 3 Months Left Eye	-55.75 autofluorescent spot count Standard Deviation 46.95

Adverse Events

Infusion of IVIG

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infusion of IVIG n=5 participants at risk Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
General disorders dizziness	20.0% 1/5 • Number of events 1 • 3 months

Additional Information

Carol Parise, PhD, Research Scientist

Sutter Institute for Medical Research

Phone: (916) 887-4744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place