Evidence map›Paper›PMID 35867135›Full record

Trial reportEuropean journal of nuclear medicine and molecular imaging2022

Neuroimaging analyses from a randomized, controlled study to evaluate plasma exchange with albumin replacement in mild-to-moderate Alzheimer's disease: additional results from the AMBAR study.

Gemma Cuberas-Borrós, Isabel Roca, Joan Castell-Conesa, Laura Núñez, Mercè Boada, Oscar L López, Carlota Grifols, Miquel Barceló, Deborah Pareto, Antonio Páez

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of nuclear medicine and molecular imaging, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01561053 (A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate Alzheimer's Disease), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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.

NCT01561053 phase2 / phase3completednot on this map

A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate Alzheimer's Disease

TypeinterventionalSponsorInstituto Grifols, S.A.Ran2012 to 2018Enrolled347ConditionsAlzheimer's DiseaseArmsAlbumin 5%, Albumin 20%, Immunoglobulin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Review
  4. Review
  5. Article
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  7. Review
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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

10 authors at 5 institutions in 2 countries.

Gemma Cuberas-BorrósResearch & Innovation Unit, Althaia Xarxa Assistencial Universitària de Manresa, Carrer Dr. Joan Soler 1-3, 08242, Manresa, Spain. gemma.cuberas.borros@gmail.com.ORCID 0000-0001-5276-8212
Isabel RocaDepartment of Nuclear Medicine, Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Barcelona, Spain.
Joan Castell-ConesaDepartment of Nuclear Medicine, Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Barcelona, Spain.
Laura NúñezAlzheimer's Research Group, Grifols, Barcelona, Spain.
Mercè BoadaAce Alzheimer Center Barcelona - Universitat Internacional de Catalunya, Barcelona, Spain.
Oscar L LópezDepartments of Neurology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Carlota GrifolsAlzheimer's Research Group, Grifols, Barcelona, Spain.
Miquel BarcelóAlzheimer's Research Group, Grifols, Barcelona, Spain.
Deborah ParetoRadiology Department (IDI), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Antonio PáezAlzheimer's Research Group, Grifols, Barcelona, Spain.
Grifols (Spain) · ESUniversitat Autònoma de Barcelona · ESInstituto de Salud Carlos III · ESUniversity of Pittsburgh · USVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study was designed to detect structural and functional brain changes in Alzheimer's disease (AD) patients treated with therapeutic plasma exchange (PE) with albumin replacement, as part of the recent AMBAR phase 2b/3 clinical trial.

methodsMild-to-moderate AD patients were randomized into four arms: three arms receiving PE with albumin (one with low-dose albumin, and two with low/high doses of albumin alternated with IVIG), and a placebo (sham PE) arm. All arms underwent 6 weeks of weekly conventional PE followed by 12 months of monthly low-volume PE. Magnetic resonance imaging (MRI) volumetric analyses and regional and statistical parametric mapping (SPM) analysis on

resultsMRI analyses (n = 198 patients) of selected subcortical structures showed fewer volume changes from baseline to final visit in the high albumin + IVIG treatment group (p < 0.05 in 3 structures vs. 4 to 9 in other groups). The high albumin + IVIG group showed no statistically significant reduction of right hippocampus. SPM

conclusionsPE with albumin replacement was associated with fewer deleterious changes in subcortical structures and less metabolic decline compared to the typical of the progression of AD. This effect was more marked in the group treated with high albumin + IVIG.

trial registration(AMBAR trial registration: EudraCT#: 2011-001,598-25; ClinicalTrials.gov ID: NCT01561053).

Indexed as

Alzheimer DiseaseAlbuminsBrainFluorodeoxyglucose F18HumansImmunoglobulins, IntravenousMagnetic Resonance ImagingNeuroimagingPlasma ExchangePositron-Emission TomographyAlbuminsFluorodeoxyglucose F18Immunoglobulins, IntravenousAlbuminAlzheimer’s diseaseIntravenous immunoglobulinPlasma exchangePlasmapheresis

Identifiers

PMID35867135
PMCPMC9606044
OpenAlexW4286447786

What OpenQuestion holds

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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.