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

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ClinicalTrials.gov Identifier: NCT01982578
Recruitment Status : Recruiting
First Posted : November 13, 2013
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Jose Vina, Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dietary Supplement: Genistein Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Activation of the Receptor PPARg/RXR as a Possible Treatment for Alzheimer's Disease. Role of Genistein.
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Genistein

Arm Intervention/treatment
Experimental: Product: Genistein
60 mg of genistein BID for 360 days. Intervention: Product: Genistein
Dietary Supplement: Genistein
Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.
Other Name: Fisiogen

Placebo Comparator: Product: Placebo
1 placebo capsule BID for 360 days. Intervention: Product: Placebo
Other: Placebo
360 days of double blind treatment of placebo.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982578


Contacts
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Contact: Jose Viña, MD PhD (hon) 0034 963864646 ext 64650 jose.vina@uv.es

Locations
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Spain
Universitat de València Recruiting
Valencia, Spain, 46010
Contact: Jose Viña, MD PhD (hon)    0034 963864646 ext 64650    jose.vina@uv.es   
Principal Investigator: Jose Viña, MD PhD (hon)         
Hospital General Universitario Recruiting
Valencia, Spain
Contact: Joaquín Escudero, MD, PhD         
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
University of Valencia
Investigators
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Principal Investigator: Jose Viña, MD PhD (hon) University of Valencia
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Responsible Party: Jose Vina, Professor M.D. Ph. D. (hon), Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT01982578    
Other Study ID Numbers: INC-GEN-2013-01
U1111-1150-4063 ( Other Identifier: World Health Organization )
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Vina, Fundación para la Investigación del Hospital Clínico de Valencia:
Treatment
Genistein
Alzheimer's disease
Cerebrospinal fluid
Amyloid beta
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists