Evidence map›Paper›PMID 27051598›Full record

ArticleBBA clinical2016

Tolerability and pharmacokinetics of oxaloacetate 100 mg capsules in Alzheimer's subjects.

Russell H Swerdlow, Rebecca Bothwell, Lewis Hutfles, Jeffrey M Burns, Gregory A Reed

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in BBA clinical, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

NCT04592354 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors

TypeinterventionalSponsorTerra Biological LLCRan2020 to 2021Enrolled40ConditionsTreatment of Fatigue After Resolution of COVID-19 InfectionArmsOxaloacetate Medical Food/Dietary Supplement
NCT05273372 nacompletednot on this mapstarted 2022, after this paper: background citation

A Randomized Double Blind Placebo Controlled Trial to Determine the Effects of Oxaloacetate on Improving Fatigue in ME/CFS

TypeinterventionalSponsorTerra Biological LLCRan2022 to 2024Enrolled82ConditionsMyalgic Encephalomyelitis, Chronic Fatigue Syndrome, FatigueArmsPlacebo, Medical Food - Anhydrous Enol-Oxaloacetate
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Therapeutics of Alzheimer's Disease: Recent Developments.Antioxidants (Basel, Switzerland) · 2022
    Review
  8. Review
  9. Review
  10. Article
  11. Safety and target engagement profile of two oxaloacetate doses in Alzheimer's patients.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2021
    Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. 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

5 authors at 1 institution in 1 country.

Russell H SwerdlowUniversity of Kansas Alzheimer's Disease Center, Kansas City, KS, USA; Department of Neurology, University of Kansas School of Medicine, Kansas City, KS, USA; Department of Biochemistry and Molecular Biology, University of Kansas School of Medicine, Kansas City, KS, USA; Department of Molecular and Integrative Physiology, University of Kansas School of Medicine, Kansas City, KS, USA.
Rebecca BothwellUniversity of Kansas Alzheimer's Disease Center, Kansas City, KS, USA.
Lewis HutflesUniversity of Kansas Alzheimer's Disease Center, Kansas City, KS, USA.
Jeffrey M BurnsUniversity of Kansas Alzheimer's Disease Center, Kansas City, KS, USA; Department of Neurology, University of Kansas School of Medicine, Kansas City, KS, USA; Department of Molecular and Integrative Physiology, University of Kansas School of Medicine, Kansas City, KS, USA.
Gregory A ReedDepartment of Pharmacology, Toxicology, and Therapeutics, University of Kansas School of Medicine, Kansas City, KS, USA.
University of Kansas · US

Funding

Transgenic & Gene-Targeting Shared ResourceP30CA168524 · NCI · UNIVERSITY OF KANSAS MEDICAL CENTER · PI NICOLE L NOLLEN · 2012 to 2026
$40.1M
University of Kansas Alzheimer's Disease Research Center (KU ADRC)P30AG072973 · NIA · UNIVERSITY OF KANSAS MEDICAL CENTER · PI JEFFREY Murray BURNS, RUSSELL H. SWERDLOW · 2021 to 2026
$25.3M
University of Kansas Alzheimer's Disease Core CentersP30AG035982 · NIA · UNIVERSITY OF KANSAS MEDICAL CENTER · PI SWERDLOW, RUSSELL H. · 2011 to 2020
$16.6M
Heartland Institute for Clinical and Translational ResearchUL1TR000001 · NCATS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BAROHN, RICHARD J. · 2012 to 2015
$13.0M
NCATS NIH HHS UL1 TR000001NCI NIH HHS P30 CA168524NIA NIH HHS P30 AG035982NIA NIH HHS P30 AG072973
6 · The paper itself

Abstract

Bioenergetics and bioenergetic-related functions are altered in Alzheimer's disease (AD) subjects. These alterations represent therapeutic targets and provide an underlying rationale for modifying brain bioenergetics in AD-affected persons. Preclinical studies in cultured cells and mice found that administering oxaloacetate (OAA), a Krebs cycle and gluconeogenesis intermediate, enhanced bioenergetic fluxes and upregulated some brain bioenergetic infrastructure-related parameters. We therefore conducted a study to provide initial data on the tolerability and pharmacokinetics of OAA in AD subjects. Six AD subjects received OAA 100 mg capsules twice a day for one month. The intervention was well-tolerated. Blood level measurements following ingestion of a 100 mg OAA capsule showed modest increases in OAA concentrations, but pharmacokinetic analyses were complicated by relatively high amounts of endogenous OAA. We conclude that OAA 100 mg capsules twice per day for one month are safe in AD subjects but do not result in a consistent and clear increase in the OAA blood level, thus necessitating future clinical studies to evaluate higher doses.

Indexed as

AD, Alzheimer's diseaseADASCog, Alzheimer's Disease Assessment Scale-Cognitive subsetAlzheimer's diseaseAUC, area under the curveCBC, complete blood countCDR, Clinical Dementia RatingClinical trialCOX, cytochrome oxidaseFDG PET, fluoro-deoxyglucose positron emission tomographyHOMA-IR, homeostatic model assessment of insulin resistanceIP, intraperitonealKU ADC, University of Kansas Alzheimer's Disease CenterLC–MS/MS, liquid chromatography–tandem mass spectrometryLFT, liver function testsMitochondriaMMSE, mini-mental state exammtDNA, mitochondrial DNAOAA, oxaloacetateOxaloacetatePGC1α, peroxisome proliferator-activated receptor gamma coactivatorPharmacokineticsPK, pharmacokinetic

Identifiers

PMID27051598
PMCPMC4816034
OpenAlexW2300064379

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.