An interventional study of Genistein and Placebo in Alzheimer's Disease, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Treatment
Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's disease (AD).
A few years ago our group reported that genistein increased PPARg (peroxisome proliferator activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases the availability of the transcription factor, it can increase apoE, and also AB degradation.
The main aim of this study is to determinate the effect of 60 mg BID of genistein administration, during 360 days, compared to placebo group, in AD patients.
Alzheimer's disease is devastating in terms of personal wellbeing as well as for society. Any effort to prevent and/or treat this disease is always sought after. Recently, an exciting new possibility was opened by modulating a cellular component called RXR-PPARG. A successful experimental treatment for Alzheimer's was found by activating RXR. But we previously showed that a component of soya, i.e., genistein, is able to activate the other part of the RXR-PPARG molecule, i.e., the PPARG moiety. Genistein, moreover, does not have the undesirable effect of bexarotene and is a food component. Our preliminary results in animals indicate that genistein is effective in the treatment of experimental Alzheimer's in mice. Epidemiological evidence shows that individuals who live in Eastern societies who have a high genistein intake (because they eat a lot of soya) have lower rates of Alzheimer's disease.
Thus we propose a controlled clinical trial to test if administration of the food component genistein is able to prevent or cure, at least partially, Alzheimer's disease.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 70 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
60 mg of genistein BID for 360 days. Intervention: Product: Genistein
Dietary Supplement: Genistein
1 placebo capsule BID for 360 days. Intervention: Product: Placebo
Other: Placebo
Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.
Also known as: Fisiogen
360 days of double blind treatment of placebo.
Changes in Amyloid beta concentration in cerebrospinal fluid (CSF)
The primary study endpoint is the change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.
Time frame: Day 0 and day 360 (plus or minus 7 day)
Changes in MMSE.
Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.
Time frame: Day 0, day 180, day 360, (plus or minus 7 days)
Changes in T@M (Memory Alteration Test).
Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.This is a memory screening test, capable for discriminating between subjects with subjective memory complaints (SMC) (without objective memory impairment) and patients with amnestic mild cognitive impairment (A-MCI) and with mild Alzheimer's disease (AD) (Archives of Gerontology and Geriatrics. 2010 Mar-Apr;50(2):171-4. doi: 10.1016/j.archger.2009.03.005. Epub 2009 Apr 16)
Time frame: Day 0, day 180, day 360, (plus or minus 7 days)
Changes in TAVEC (Verbal Learning Test Spain-COmplutense).
Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.
Time frame: Day 0, day 180, day 360, (plus or minus 7 days)
Changes in the Clock test.
Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.
Time frame: Day 0, day 180, day 360, (plus or minus 7 days)
Changes in the Barcelona Test.
Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.
Time frame: Day 0, day 180, day 360, (plus or minus 7 days)
Changes in Rey Complex figure Test.
Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.
Time frame: Day 0, day 180, day 360, (plus or minus 7 days)
Changes in Genistein Pharmacokinetics.
Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group.
Time frame: Day 0, day 360, (plus or minus 7 days)
Changes in Equol Pharmacokinetics.
Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group.
Time frame: Day 0, day 360, (plus or minus 7 days)
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Fundación para la Investigación del Hospital Clínico de Valencia