Evidence map›Paper›PMID 33074237›Full record

Trial reportJournal of Alzheimer's disease : JAD2020

Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.

Gary E Gibson, José A Luchsinger, Rosanna Cirio, Huanlian Chen, Jessica Franchino-Elder, Joseph A Hirsch, Lucien Bettendorff, Zhengming Chen, Sarah A Flowers, Linda M Gerber and 7 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of Alzheimer's disease : JAD, 2020. 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 62 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 3 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT02292238 phase2completednot on this map

Benfotiamine in Alzheimer's Disease: A Pilot Study

TypeinterventionalSponsorBurke Medical Research InstituteRan2015 to 2020Enrolled71ConditionsAlzheimer's DiseaseArmsBenfotiamine
NCT06223360 phase2active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

TypeinterventionalSponsorAlzheimer's Disease Cooperative Study (ADCS)Ran2024 to 2027Enrolled406ConditionsAlzheimer DiseaseArmsLow Dose Benfotiamine, High Dose Benfotiamine, Placebo
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 3 syntheses or guidelines pooled it, 101 citations in OpenAlex.

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  20. Reinforcing Nrf2 Signaling: Help in the Alzheimer's Disease Context.International journal of molecular sciences · 2025
    Review

2 more citing papers are in PubMed but not listed here.

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

17 authors at 11 institutions in 2 countries.

Gary E GibsonBrain and Mind Research Institute, Weil Cornell Medicine, New York, NY, USA.
José A LuchsingerDepartments of Medicine and Epidemiology, Columbia University Irving Medical Center, New York, NY, USA.
Rosanna CirioBurke Neurological Institute, White Plains, NY, USA.
Huanlian ChenBurke Neurological Institute, White Plains, NY, USA.
Jessica Franchino-ElderBurke Neurological Institute, White Plains, NY, USA.
Joseph A HirschBurke Neurological Institute, White Plains, NY, USA.
Lucien BettendorffLaboratory of Neurophysiology, GIGA-Neurosciences, University of Liege, Belgium.
Zhengming ChenDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Sarah A FlowersDepartment of Neuroscience, Georgetown University, Washington, DC, USA.
Linda M GerberDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Thomas GrandvilleBurke Rehabilitation Hospital, White Plains, NY, USA.
Nicole SchupfMailman School of Public Health, The Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Irving Medical Center, New York, NY, USA.
Hui XuBurke Neurological Institute, White Plains, NY, USA.
Yaakov SternDepartments of Neurology, Psychiatry, GH Sergievsky Center, the Taub Institute for the Research on Alzheimer's Disease and the Aging Brain, Columbia University Irving Medical Center, New York, NY, USA.
Christian HabeckDepartment of Neurology and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Irving Medical Center, New York, NY, USA.
Barry JordanRancho Los Amigos National Rehabilitation Center, Downey, CA, USA.
Pasquale FonzettiEinstein College of Medicine, Bronx NY; Westmed Medical Group White Plains, NY, USA.
Burke Medical Research Institute · USColumbia University Irving Medical Center · USBurke Rehabilitation Hospital · USAlbert Einstein College of Medicine · USColumbia University · USCornell University · USGeorgetown University · USMIND Research Institute · USRancho Los Amigos National Rehabilitation Center · USUniversity of Liège · BEWeill Cornell Medicine · US

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
Metformin in Alzheimer's dementia Prevention (MAP)R01AG062624 · NIA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HANLEY, DANIEL F, LUCHSINGER, JOSE ALEJANDRO · 2019 to 2025
$37.8M
Benfotiamine in Alzheimer's Disease: A pilot studyR01AG043679 · NIA · WINIFRED MASTERSON BURKE MED RES INST · PI FONZETTI, PASQUALE, GIBSON, GARY E · 2014 to 2018
$1.8M
Midcareer Award for Research in Dementia Risk Factors and PreventionK24AG045334 · NIA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Jose Alejandro Luchsinger · 2016 to 2026
$1.5M
Apolipoprotein E glycosylation and its role in Alzheimer's disease pathogenesisR56AG062305 · NIA · GEORGETOWN UNIVERSITY · PI FLOWERS, SARAH ANN · 2018 to 2019
$778k
NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR002384NIA NIH HHS K24 AG045334NIA NIH HHS R01 AG043679NIA NIH HHS R01 AG062624NIA NIH HHS R56 AG062305
6 · The paper itself

Abstract

backgroundIn preclinical models, benfotiamine efficiently ameliorates the clinical and biological pathologies that define Alzheimer's disease (AD) including impaired cognition, amyloid-β plaques, neurofibrillary tangles, diminished glucose metabolism, oxidative stress, increased advanced glycation end products (AGE), and inflammation.

objectiveTo collect preliminary data on feasibility, safety, and efficacy in individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine.

methodsA twelve-month treatment with benfotiamine tested whether clinical decline would be delayed in the benfotiamine group compared to the placebo group. The primary clinical outcome was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). Secondary outcomes were the clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET). Blood AGE were examined as an exploratory outcome.

resultsParticipants were treated with benfotiamine (34) or placebo (36). Benfotiamine treatment was safe. The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125). Worsening in CDR was 77% lower (p = 0.034) in the benfotiamine group compared to the placebo group, and this effect was stronger in the APOEɛ4 non-carriers. Benfotiamine significantly reduced increases in AGE (p = 0.044), and this effect was stronger in the APOEɛ4 non-carriers. Exploratory analysis derivation of an FDG PET pattern score showed a treatment effect at one year (p = 0.002).

conclusionOral benfotiamine is safe and potentially efficacious in improving cognitive outcomes among persons with MCI and mild AD.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAniline CompoundsApolipoprotein E4BrainCognitive DysfunctionDisease ProgressionEthylene GlycolsFemaleFluorodeoxyglucose F18Glycation End Products, AdvancedHumansMalePositron-Emission TomographyRadiopharmaceuticalsAniline CompoundsApolipoprotein E4benphothiamineEthylene GlycolsflorbetapirFluorodeoxyglucose F18Glycation End Products, AdvancedRadiopharmaceuticalsThiamineAdvanced glycation endproductsAlzheimer’s diseasebenfotiamineglucoseinflammationoxidative stress

Identifiers

PMID33074237
PMCPMC7880246
OpenAlexW3093472207

What OpenQuestion holds

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LicenceTDM
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.