Evidence map›Paper›PMID 29067300›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2016

Demonstration of safety of intravenous immunoglobulin in geriatric patients in a long-term, placebo-controlled study of Alzheimer's disease.

David Gelmont, Ronald G Thomas, Jonathan Britt, Jacqueline A Dyck-Jones, Jennifer Doralt, Sandor Fritsch, James B Brewer, Robert A Rissman, Paul Aisen

Open access · goldAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 3 pooled it
0.2field-weighted citation impact, top 39% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 syntheses or guidelines pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
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 4 institutions in 2 countries.

David GelmontClinical Development, Baxalta US Inc., Westlake Village, CA, USA.
Ronald G ThomasADCS Alzheimer's Disease Cooperative Study, UCSD, La Jolla, CA, USA.
Jonathan BrittClinical Development, Baxalta US Inc., Westlake Village, CA, USA.
Jacqueline A Dyck-JonesClinical Development, Baxalta US Inc., Westlake Village, CA, USA.
Jennifer DoraltClinical Development, Baxalta Innovations GmbH, Vienna, Austria.
Sandor FritschClinical Development, Baxalta Innovations GmbH, Vienna, Austria.
James B BrewerADCS Alzheimer's Disease Cooperative Study, UCSD, La Jolla, CA, USA.
Robert A RissmanADCS Alzheimer's Disease Cooperative Study, UCSD, La Jolla, CA, USA.
Paul AisenUSC Alzheimer's Therapeutic Research Institute, San Diego, CA, USA.
Alzheimer’s Disease Neuroimaging Initiative · USBaxter (Austria) · ATInstrumental Polymer Technologies (United States) · USBaxalta (United States) · US

Funding

TRIAL OF VALPROATE TO ATTENUATE THE PROGRESSION OF ADU01AG010483 · NIA · UNIVERSITY OF ROCHESTER · PI AISEN, PAUL S. · 1991 to 2012
$116.2M
NIA NIH HHS U01 AG010483
6 · The paper itself

Abstract

introductionWe present safety results from a study of Gammagard Liquid intravenous immunoglobulin (IGIV) in patients with probable Alzheimer's disease.

methodsThis was a placebo-controlled double-blind study. Subjects were randomized to 400 mg/kg (n = 127), 200 mg/kg (n = 135) IGIV, or to 0.25% human albumin (n = 121) administered every 2 weeks ± 7 days for 18 months.

resultsElevated risk ratios of IGIV versus placebo included chills (3.85) in 9.5% of IGIV-treated subjects (all doses), compared to 2.5% of placebo-treated subjects, and rash (3.08) in 15.3% of IGIV-treated subjects versus 5.0% of subjects treated with placebo. Subjects in the highest IGIV dose group had the lowest proportion of SAEs considered related to product (2 of 127 [1.6%]). Subjects treated with IGIV experienced a lower rate of respiratory and all other infections compared to placebo. DISCUSSION: IGIV-treated subjects did not experience higher rates of renal failure, lung injury, or thrombotic events than the placebo group. There were no unexpected safety findings. IGIV was well tolerated throughout 18 months of treatment in subjects aged 50-89 years.

Indexed as

Adverse eventsAlzheimer's diseaseIGIVIntravenous immunoglobulinSafety of IGIV

Identifiers

PMID29067300
PMCPMC5644268
OpenAlexW2465048718

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.