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.

Brief Title

Genistein as a Possible Treatment for Alzheimer's Disease.

Official Title

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

Brief Summary

Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's <br /> disease (AD). <br /> <br /> A few years ago our group reported that genistein increased PPARg (peroxisome proliferator <br /> activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg <br /> dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of <br /> amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases <br /> the availability of the transcription factor, it can increase apoE, and also AB degradation. <br /> <br /> The main aim of this study is to determinate the effect of 60 mg BID of genistein <br /> administration, during 360 days, compared to placebo group, in AD patients.

Detailed Description

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Inclusion Criteria:

  -  Patients with mild cognitive impairment (MCI) compatible with prodromal AD.

  -  Mini-Mental State Examinations (MMSE) score between over 24 inclusive.

  -  CSF levels of AB, p-TAU compatible with AD.

  -  18 years or older.

  -  Must have a study partner who is able and willing to comply with all required study
     procedures.

  -  Willing and able to provide informed consent by either the subject or subject's legal
     representative.

Exclusion Criteria:

  -  Patient who does not meet the inclusion criteria.

  -  Thyroid abnormalities with or without treatment.

  -  Immune abnormalities in blood analyses.

  -  Patient suffers hormone dependent neoplasia.

  -  Take a diet rich on isoflavones.