Evidence map›Paper›PMID 34362303›Full record

Trial reportBMC neuroscience2021

Five-year outcomes after IVIG for mild cognitive impairment due to alzheimer disease.

Shawn Kile, William Au, Carol Parise, Kimberley Rose, Tammy Donnel, Andrea Hankins, Yvonne Au, Matthew Chan, Azad Ghassemi

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neuroscience, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01300728 (A Randomized Double-Blinded Placebo-Controlled Exploratory Study of Intravenous Immunoglobulin), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01300728 phase2completednot on this map

A Randomized Double-Blinded Placebo-Controlled Exploratory Study of Intravenous Immunoglobulin (NewGam 10%) in Amnestic Mild Cognitive Impairment

TypeinterventionalSponsorSutter HealthRan2011 to 2020Enrolled52ConditionsMild Cognitive ImpairmentArmsNewGam 10% IVIG, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Shawn KileSutter Neuroscience Institute, 2800 L Street, Suite 500, Sacramento, CA, 95816, USA. kiles@sutterhealth.org.ORCID 0000-0001-7906-4186
William AuSutter Neuroscience Institute, 2800 L Street, Suite 500, Sacramento, CA, 95816, USA.
Carol PariseSutter Institute for Medical Research (SIMR), Sacramento, CA, USA.
Kimberley RoseSutter Neuroscience Institute, 2800 L Street, Suite 500, Sacramento, CA, 95816, USA.
Tammy DonnelSutter Institute for Medical Research (SIMR), Sacramento, CA, USA.
Andrea HankinsSutter Institute for Medical Research (SIMR), Sacramento, CA, USA.
Yvonne AuSutter Neuroscience Institute, 2800 L Street, Suite 500, Sacramento, CA, 95816, USA.
Matthew ChanSutter Imaging, Neuroradiology, Sacramento, USA.
Azad GhassemiSutter Imaging, Neuroradiology, Sacramento, USA.
Sutter Health · USSutter Institute for Medical Research · USSutter Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this study was to assess the five-year treatment effects of a short course of intravenous immunoglobulin (IVIG) in subjects with mild cognitive impairment (MCI) due to Alzheimer disease (AD).

methodsFifty subjects 50 to 84 years of age with MCI due to AD were administered 0.4 g/kg 10% IVIG or 0.9% saline every two weeks x five doses in a randomized double-blinded design as part of a two-year study. Twenty-seven subjects completed an additional three-year extension study. MRI brain imaging, cognitive testing, and conversion to dementia were assessed annually. Participants were stratified into early MCI (E-MCI) and late MCI (L-MCI). The primary endpoint was brain atrophy measured as annualized percent change in ventricular volume (APCV) annually for five years. ANOVA was used to compare annualized percent change in ventricular volume from baseline between the groups adjusting for MCI status (E-MCI, L-MCI).

resultsDifferences in brain atrophy between the groups, which were statistically significant after one year, were no longer significant after five years. IVIG-treated L-MCI subjects did demonstrate a delay in conversion to dementia of 21.4 weeks.

conclusionAn eight-week course of IVIG totaling 2 g/kg in MCI is safe but is not sufficient to sustain an initial reduction in brain atrophy or a temporary delay in conversion to dementia at five years. Other dosing strategies of IVIG in the early stages of AD should be investigated to assess more sustainable disease-modifying effects. Trial registration ClinicalTrials.gov NCT01300728. Registered 23 February 2011.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseCognitive DysfunctionDouble-Blind MethodFemaleFollow-Up StudiesHumansImmunoglobulins, IntravenousMaleMiddle Agedtau ProteinsTime FactorsTreatment OutcomeImmunoglobulins, IntravenousMAPT protein, humantau ProteinsAlzheimer’s diseaseIntravenous immunoglobulin (IVIG)Mild cognitive impairment (MCI)Ventricular volume

Identifiers

PMID34362303
PMCPMC8349062
OpenAlexW3189149764

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.