Genistein as a Possible Treatment for Alzheimer's Disease.
NCT ID: NCT01982578
Last Updated: 2021-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2017-09-01
2020-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Product: Genistein
60 mg of genistein BID for 360 days. Intervention: Product: Genistein
Genistein
Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.
Product: Placebo
1 placebo capsule BID for 360 days. Intervention: Product: Placebo
Placebo
360 days of double blind treatment of placebo.
Interventions
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Genistein
Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.
Placebo
360 days of double blind treatment of placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Thyroid abnormalities with or without treatment.
* Immune abnormalities in blood analyses.
* Patient suffers hormone dependent neoplasia.
* Take a diet rich on isoflavones.
18 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Jose Vina
Professor M.D. Ph. D. (hon)
Principal Investigators
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Jose Viña, MD PhD (hon)
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Locations
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Universitat de València
Valencia, , Spain
Hospital General Universitario
Valencia, , Spain
Countries
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References
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Vina J, Escudero J, Baquero M, Cebrian M, Carbonell-Asins JA, Munoz JE, Satorres E, Melendez JC, Ferrer-Rebolleda J, Cozar-Santiago MDP, Santabarbara-Gomez JM, Jove M, Pamplona R, Tarazona-Santabalbina FJ, Borras C. Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial. Alzheimers Res Ther. 2022 Nov 4;14(1):164. doi: 10.1186/s13195-022-01097-2.
Other Identifiers
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U1111-1150-4063
Identifier Type: OTHER
Identifier Source: secondary_id
INC-GEN-2013-01
Identifier Type: -
Identifier Source: org_study_id
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