Genistein as a Possible Treatment for Alzheimer's Disease. (GENIAL)

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Other: Placebo; Dietary Supplement: Genistein

Study type: Interventional

Funder types: Other

Identifiers

NCT01982578

INC-GEN-2013-01

U1111-1150-4063 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Product: Genistein

Experimental group

Description:

60 mg of genistein BID for 360 days. Intervention: Product: Genistein

Treatment:

Dietary Supplement: Genistein

Product: Placebo

Placebo Comparator group

Description:

1 placebo capsule BID for 360 days. Intervention: Product: Placebo

Treatment:

Other: Placebo