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Alzheimer's DiseaseGENIALNCT01982578

Genistein as a Possible Treatment for Alzheimer's Disease.

A study testing Genistein in people with Alzheimer's Disease, run by Fundación para la Investigación del Hospital Clínico de Valencia at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Genistein
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
2 sitesSpain
Study dates
1 Sep 2017to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Universitat de València

    Valencia, 46010

  • Hospital General Universitario

    Valencia

Other trials in Spain

About this study

Official title: Effect of Activation of the Receptor PPARg/RXR as a Possible Treatment for Alzheimer's Disease. Role of Genistein.

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.

Read the 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.

Being tested
Genistein, Placebo
Keywords
Treatment, Genistein, Alzheimer's disease, Cerebrospinal fluid, Amyloid beta
Medical subject headings
Alzheimer Disease, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenisteinDietary supplement

    Also called Fisiogen

    Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.

  • PlaceboOther

    360 days of double blind treatment of placebo.

Study groups in NCT01982578
Study groupRoleWhat they receive
Product: GenisteinExperimental60 mg of genistein BID for 360 days. Intervention: Product: Genistein
Receives: Dietary Supplement: Genistein
Product: PlaceboPlacebo comparator1 placebo capsule BID for 360 days. Intervention: Product: Placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0 and day 360 (plus or minus 7 day)

Secondary outcomes (8)

  1. Changes in MMSE.

    Change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

    Measured: Day 0, day 180, day 360, (plus or minus 7 days)

  2. Changes in T@M (Memory Alteration Test).

    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)

    Measured: Day 0, day 180, day 360, (plus or minus 7 days)

  3. 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.

    Measured: Day 0, day 180, day 360, (plus or minus 7 days)

  4. 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.

    Measured: Day 0, day 180, day 360, (plus or minus 7 days)

  5. 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.

    Measured: Day 0, day 180, day 360, (plus or minus 7 days)

  6. 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.

    Measured: Day 0, day 180, day 360, (plus or minus 7 days)

  7. Changes in Genistein Pharmacokinetics.

    Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group.

    Measured: Day 0, day 360, (plus or minus 7 days)

  8. Changes in Equol Pharmacokinetics.

    Change from baseline to the end of the treatment,and the change between the treatment group and the placebo group.

    Measured: Day 0, day 360, (plus or minus 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2013 (estimated)
  2. Study start1 Sep 2017
  3. Primary completion30 Sep 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982578
Sponsor's protocol ID
INC-GEN-2013-01
Other IDs
U1111-1150-4063
Acronym
GENIAL
Status last verified
Sep 2021
First submitted
30 Oct 2013
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36329553

Questions about this trial

What is this clinical trial studying?

A study testing Genistein in people with Alzheimer's Disease, run by Fundación para la Investigación del Hospital Clínico de Valencia at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Amyloid beta concentration in cerebrospinal fluid (CSF) (time frame: Day 0 and day 360 (plus or minus 7 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01982578, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.

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