Portal de investigación
Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial.
Fecha de publicación:
Fecha Ahead of Print:
Autores de INCLIVA
Participantes ajenos a INCLIVA
- Escudero, J
- Baquero, M
- Cebrian, M
- Munoz, JE
- Satorres, E
- Melendez, JC
- Ferrer-Rebolleda, J
- Cozar-Santiago, MD
- Santabarbara-Gomez, JM
- Jove, M
- Pamplona, R
- Tarazona-Santabalbina, FJ
Grupos y Plataformas de I+D+i
Abstract
BACKGROUND: Delaying 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. METHODS: In 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. RESULTS: We 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. CONCLUSIONS: This 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 REGISTRATION: NCT01982578, registered on November 13, 2013.
© 2022. The Author(s).
Datos de la publicación
- ISSN/ISSNe:
- 1758-9193, 1758-9193
- Tipo:
- Article
- Páginas:
- 164-164
- PubMed:
- 36329553
Alzheimers Research & Therapy BioMed Central
Citas Recibidas en Web of Science: 37
Documentos
Filiaciones
Keywords
- Amyloid-beta cingulate gyrus; Cognitive impairment; Phytoestrogens; Soy isoflavones
Financiación
Proyectos y Estudios Clínicos
INCORPORACIÓN DE NUEVAS ÁREAS TEMÁTICAS Y NUEVOS GRUPOS AL CONSORCIO CIBER
Investigador Principal: JOSE VIÑA RIBES
CB16/10/00435 . INSTITUTO SALUD CARLOS III
Scaling-up of and evidence-based intervention programme in older people with Diabetes and Frailty in LatinAmericam. DIABFRAIL-LATAM: DR. JOSÉ VIÑA 2018
Investigador Principal: JOSE VIÑA RIBES
825546 . EUROPEAN COMMISSION . 2019
Cita
Vina J,Escudero J,Baquero M,Cebrian M,Carbonell JA,Munoz JE,Satorres E,Melendez JC,Ferrer J,Cozar MD,Santabarbara JM,Jove M,Pamplona R,Tarazona FJ,Borras C. Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial. Alzheimers Res. Ther. 2022. 14. (1):p. 164-164. IF:9,000. (1).
Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial. Vina J, Escudero J, Baquero M, Cebrian M, Carbonell JA, Munoz JE, Satorres E et al. Alzheimers Research & Therapy. 2022 noviembre 04. 14 (1):164-164. DOI:10.1186/s13195-022-01097-2. PMID:36329553.
