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NCT Number: NCT01982578

Genistein as a Possible Treatment for Alzheimer's Disease.

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario, Valencia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genistein

Dietary Supplement

Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.

Other names: Fisiogen

Placebo

Other

360 days of double blind treatment of placebo.

Primary outcomes

  1. Changes in Amyloid beta concentration in cerebrospinal fluid (CSF)

    Time frame: Day 0 and day 360 (plus or minus 7 day)

    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.

Secondary outcomes

  1. Changes in MMSE.

    Time frame: Day 0, day 180, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

  2. Changes in T@M (Memory Alteration Test).

    Time frame: Day 0, day 180, day 360, (plus or minus 7 days)

    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)

  3. Changes in TAVEC (Verbal Learning Test Spain-COmplutense).

    Time frame: Day 0, day 180, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

  4. Changes in the Clock test.

    Time frame: Day 0, day 180, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

  5. Changes in the Barcelona Test.

    Time frame: Day 0, day 180, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

  6. Changes in Rey Complex figure Test.

    Time frame: Day 0, day 180, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

  7. Changes in Genistein Pharmacokinetics.

    Time frame: Day 0, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group.

  8. Changes in Equol Pharmacokinetics.

    Time frame: Day 0, day 360, (plus or minus 7 days)

    Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • University of Valencia

Registry information

Official study title

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

Acronym: GENIAL

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2013
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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