Evidence map›Paper›PMID 36329553›Full record

Trial reportAlzheimer's research & therapy2022

Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial.

José Viña, Joaquín Escudero, Miquel Baquero, Mónica Cebrián, Juan Antonio Carbonell-Asíns, José Enrique Muñoz, Encarnación Satorres, Juan Carlos Meléndez, José Ferrer-Rebolleda, Mª Del Puig Cózar-Santiago and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01982578 (Effect of Activation of the Receptor PPARg/RXR as a Possible Treatment for Alzheimer's Disease. Role of Genistein.), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01982578 nacompletednot on this map

Effect of Activation of the Receptor PPARg/RXR as a Possible Treatment for Alzheimer's Disease. Role of Genistein.

TypeinterventionalSponsorFundación para la Investigación del Hospital Clínico de ValenciaRan2017 to 2020Enrolled27ConditionsAlzheimer's DiseaseArmsGenistein, Placebo
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  8. Journal of medicinal chemistry · 2026
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  19. Reinforcing Nrf2 Signaling: Help in the Alzheimer's Disease Context.International journal of molecular sciences · 2025
    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

15 authors.

José ViñaFreshage Research Group, Department of Physiology, Faculty of Medicine, University of Valencia, and CIBERFES, Insitute of Health Research-INCLIVA, Avenida Blasco Ibáñez 15, 46010, Valencia, Spain.
Joaquín EscuderoHospital General of Valencia, Av. Tres Cruces 2, ES, 46014, Valencia, Spain.
Miquel BaqueroNeurology Unit, University and Polytechnic Hospital La Fe, Valencia, Spain.
Mónica CebriánFreshage Research Group, Department of Physiology, Faculty of Medicine, University of Valencia, and CIBERFES, Insitute of Health Research-INCLIVA, Avenida Blasco Ibáñez 15, 46010, Valencia, Spain.
Juan Antonio Carbonell-AsínsDepartment of Bioinformatics and Biostatistics, Insitute of Health Research-INCLIVA, Valencia, Spain.
José Enrique MuñozPharmacy Department, Hospital Clínico Universitario de Valencia/INCLIVA Health Research Institute, Valencia, Spain.
Encarnación SatorresDepartment of Developmental Psychology, Faculty of Psychology, University of Valencia, ES 46002, Valencia, Spain.
Juan Carlos MeléndezDepartment of Developmental Psychology, Faculty of Psychology, University of Valencia, ES 46002, Valencia, Spain.
José Ferrer-RebolledaNuclear Medicine Department, Ascires Biomedical Group, Valencia, Spain.
Mª Del Puig Cózar-SantiagoNuclear Medicine Department, Ascires Biomedical Group, Valencia, Spain.
Jose Manuel Santabárbara-GómezNuclear Medicine Department, Ascires Biomedical Group, Valencia, Spain.
Mariona JovéDepartment of Experimental Medicine, University of Lleida-Lleida Biomedical Research Institute (UdL-IRBLleida), E-25198, Lleida, Spain.
Reinald PamplonaDepartment of Experimental Medicine, University of Lleida-Lleida Biomedical Research Institute (UdL-IRBLleida), E-25198, Lleida, Spain.
Francisco José Tarazona-SantabalbinaDepartment of Geriatrics, La Ribera Hospital, Alcira, Valencia, Spain.
Consuelo BorrásFreshage Research Group, Department of Physiology, Faculty of Medicine, University of Valencia, and CIBERFES, Insitute of Health Research-INCLIVA, Avenida Blasco Ibáñez 15, 46010, Valencia, Spain. consuelo.borras@uv.es.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDelaying the transition from minimal cognitive impairment to Alzheimer's dementia is a major concern in Alzheimer's disease (AD) therapeutics. Pathological signs of AD occur years before the onset of clinical dementia. Thus, long-term therapeutic approaches, with safe, minimally invasive, and yet effective substances are recommended. There is a need to develop new drugs to delay Alzheimer's dementia. We have taken a nutritional supplement approach with genistein, a chemically defined polyphenol that acts by multimodal specific mechanisms. Our group previously showed that genistein supplementation is effective to treat the double transgenic (APP/PS1) AD animal model.

methodsIn this double-blind, placebo-controlled, bicentric clinical trial, we evaluated the effect of daily oral supplementation with 120 mg of genistein for 12 months on 24 prodromal Alzheimer's disease patients. The amyloid-beta deposition was analyzed using 18F-flutemetamol uptake. We used a battery of validated neurocognitive tests: Mini-Mental State Exam (MMSE), Memory Alteration Test (M@T), Clock Drawing Test, Complutense Verbal Learning Test (TAVEC), Barcelona Test-Revised (TBR), and Rey Complex Figure Test.

resultsWe report that genistein treatment results in a significant improvement in two of the tests used (dichotomized direct TAVEC, p = 0.031; dichotomized delayed Centil REY copy p = 0.002 and a tendency to improve in all the rest of them. The amyloid-beta deposition analysis showed that genistein-treated patients did not increase their uptake in the anterior cingulate gyrus after treatment (p = 0.878), while placebo-treated did increase it (p = 0.036). We did not observe significant changes in other brain areas studied.

conclusionsThis study shows that genistein may have a role in therapeutics to delay the onset of Alzheimer's dementia in patients with prodromal Alzheimer's disease. These encouraging results indicate that this should be followed up by a new study with more patients to further validate the conclusion that arises from this study.

trial registrationNCT01982578, registered on November 13, 2013.

Indexed as

Alzheimer DiseaseCognitive DysfunctionAmyloid beta-PeptidesCognitionGenisteinHumansAmyloid beta-PeptidesGenisteinAmyloid-beta cingulate gyrusCognitive impairmentPhytoestrogensSoy isoflavones

Identifiers

PMID36329553
PMCPMC9635167

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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.