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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1150-4063 | Other Identifier | World Health Organization |
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| Name | Class |
|---|---|
| University of Valencia | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product: Genistein | Experimental | 60 mg of genistein BID for 360 days. Intervention: Product: Genistein |
|
| Product: Placebo | Placebo Comparator | 1 placebo capsule BID for 360 days. Intervention: Product: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Dietary Supplement | Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 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. | Day 0 and day 360 (plus or minus 7 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in MMSE. | Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group. | Day 0, day 180, day 360, (plus or minus 7 days) |
| Changes in T@M (Memory Alteration Test). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Viña, MD PhD (hon) | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat de València | Valencia | 46010 | Spain | |||
| Hospital General Universitario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36329553 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 3, 2022 | |
| Reset | Mar 14, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2022 | Mar 14, 2023 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Placebo | Other | 360 days of double blind treatment of placebo. |
|
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)
| Day 0, day 180, day 360, (plus or minus 7 days) |
| Changes in TAVEC (Verbal Learning Test Spain-COmplutense). | Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group. | Day 0, day 180, day 360, (plus or minus 7 days) |
| Changes in the Clock test. | Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group. | Day 0, day 180, day 360, (plus or minus 7 days) |
| Changes in the Barcelona Test. | Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group. | Day 0, day 180, day 360, (plus or minus 7 days) |
| Changes in Rey Complex figure Test. | Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group. | Day 0, day 180, day 360, (plus or minus 7 days) |
| Changes in Genistein Pharmacokinetics. | Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group. | Day 0, day 360, (plus or minus 7 days) |
| Changes in Equol Pharmacokinetics. | Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group. | Day 0, day 360, (plus or minus 7 days) |
| Valencia |
| Spain |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |