Genistein as a Possible Treatment for Alzheimer's Disease. (GENISTEÍNA_2)
|
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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01982578 |
|
Recruitment Status : Unknown
Verified July 2015 by Jose Vina, Fundación para la Investigación del Hospital Clínico de Valencia.
Recruitment status was: Recruiting
First Posted : November 13, 2013
Last Update Posted : August 3, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Dietary Supplement: Genistein Other: Placebo | Not Applicable |
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.
| 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. |
| Study Start Date : | November 2013 |
| Estimated Primary Completion Date : | September 2017 |
| Estimated Study Completion Date : | September 2018 |
| Arm | Intervention/treatment |
|---|---|
|
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. |
- 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) ]
- 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) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: Jose Viña, MD PhD (hon) | 0034 963864646 ext 64650 | jose.vina@uv.es |
| 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) | |
| Principal Investigator: | Jose Viña, MD PhD (hon) | University of Valencia |
| 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 Posted: | November 13, 2013 Key Record Dates |
| 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 |