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Genistein as a Possible Treatment for Alzheimer's Disease. (GENISTEÍNA_2)

This study is currently recruiting participants.
Verified July 2015 by Jose Vina, Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982578
First Posted: November 13, 2013
Last Update Posted: August 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Jose Vina, Fundación para la Investigación del Hospital Clínico de Valencia
  Purpose

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 180 days, compared to placebo group, in AD patients.


Condition Intervention
Alzheimer's Disease Dietary Supplement: Genistein Other: Placebo

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Jose Vina, Fundación para la Investigación del Hospital Clínico de Valencia:

Primary Outcome Measures:
  • 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 180 (plus or minus 3 day) ]

Secondary Outcome Measures:
  • 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 45, day 180, (plus or minus 3 days) ]
  • Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). 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 45, day 180, (plus or minus 3 days) ]
  • Memory alteration test (M@t). 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 45, day 180, (plus or minus 3 days) ]
    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)

  • Neuropsychiatric Inventory (NPI). 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 45, day 180, (plus or minus 3 days) ]
  • Barthel index. 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 45, day 180, (plus or minus 3 days) ]
  • P-TAU concentration in CSF. 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 180 (plus or minus 3 day) ]

Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Product: Genistein
60 mg of genistein BID for 180 days. Intervention: Product: Genistein
Dietary Supplement: Genistein
Subjects will be randomized 1:1 to receive 180 days of double blind treatment of genistein.
Other Name: Fisiogen
Placebo Comparator: Product: Placebo
1 placebo capsule BID for 180 days. Intervention: Product: Placebo
Other: Placebo
180 days of double blind treatment of placebo.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
Contact: Jose Viña, MD PhD (hon) 0034 963864646 ext 64650 jose.vina@uv.es

Locations
Spain
Hospital de La Ribera Recruiting
Alzira, Valencia, Spain, 46600
Contact: Francisco Tarazona, MD    +34 962 458 100    FJTarazona@Hospital-Ribera.com   
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: José Miguel Lainez, M.D.    963 86 26 00    jlaineza@medynet.com   
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)         
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
University of Valencia
Investigators
Principal Investigator: Jose Viña, MD PhD (hon) University of Valencia
  More Information

Responsible Party: Jose Vina, Professor M.D. Ph. D. (hon), Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT01982578     History of Changes
Other Study ID Numbers: INC-GEN-2013-01
U1111-1150-4063 ( Other Identifier: World Health Organization )
First Submitted: October 30, 2013
First Posted: November 13, 2013
Last Update Posted: August 3, 2015
Last Verified: July 2015

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:
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


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